EP1171116A1 - Methode de prevention ou reduction d'incidents cardio-vasculaires associes a une intervention coronarienne - Google Patents

Methode de prevention ou reduction d'incidents cardio-vasculaires associes a une intervention coronarienne

Info

Publication number
EP1171116A1
EP1171116A1 EP00904640A EP00904640A EP1171116A1 EP 1171116 A1 EP1171116 A1 EP 1171116A1 EP 00904640 A EP00904640 A EP 00904640A EP 00904640 A EP00904640 A EP 00904640A EP 1171116 A1 EP1171116 A1 EP 1171116A1
Authority
EP
European Patent Office
Prior art keywords
days
coronary intervention
treatment period
pharmaceutically acceptable
acceptable salt
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP00904640A
Other languages
German (de)
English (en)
Other versions
EP1171116A4 (fr
Inventor
Jeffrey R. Granett
Neil H. Shusterman
David C. U'prichard
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
SmithKline Beecham Corp
Original Assignee
SmithKline Beecham Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by SmithKline Beecham Corp filed Critical SmithKline Beecham Corp
Publication of EP1171116A1 publication Critical patent/EP1171116A1/fr
Publication of EP1171116A4 publication Critical patent/EP1171116A4/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Definitions

  • the present invention relates to a method for the prevention or reduction of cardiovascular events associated with coronary intervention.
  • the method comprises administrating to a mammal, particularly a human patient, after coronary intervention an oral or parental dose of N-(3',4 - dimethoxycinnamoyl)anthranilic acid (N-5 * ) (Tranilast) represented by the following formula (I) or a pharmaceutically acceptable salt thereof as an active ingredient.
  • N-5 * N-(3',4 - dimethoxycinnamoyl)anthranilic acid
  • Trnilast represented by the following formula (I) or a pharmaceutically acceptable salt thereof as an active ingredient.
  • Coronary intervention is a percutaneous procedural approach to the treatment of ischemic heart disease such as angina pectoris and myocardial infarction.
  • Coronary intervention technically involves mechanical revascularization of a stenosed lesion in a coronary artery by means of a balloon catheter, mechanical stent placement, an atherectomy catheter and the like.
  • coronary intervention often causes restenosis due to damaged intima and media cells. Patients who experience restenosis may require revascularization procedures to correct the condition.
  • Other cardiovascular events associated with coronary intervention include myocardial infarction and death.
  • Tranilast is sold commercially as a drug for the treatment of allergic diseases, e.g., allergic bronchitis, allergic asthma, atopic dermatitis, and the like, based on the activity exhibited by the drug for inhibiting release of chemical mediators [The Journal of Allergy and Clinical Immunology, Vol. 57, No. 5, pp. 396-407, (1976)].
  • T e 35 patent indicates that the lack of efficacy for inhibiting a restenosis effect with Tranilast after the 30 day protocol was due to a too short duration of treatment.
  • the 935 patent demonstrated that an extended period of Tranilast treatment was effective for lowering the incidence of post-procedure restenosis associated with PTCA. It was found that dosing patients with Tranilast for a duration of at least about three months (i.e., a term of at least about 90 consecutive days of treatment) reduced the incidence of restenosis associated with the PTCA procedure. In one clinical study, when patients were administered Tranilast in a daily oral dose of 600 mg for three consecutive months after the PTCA procedure, the incidence of restenosis was less than about 20%. As reported in the * 935 patent, the incidence of restenosis associated with the PTCA procedure usually is about 40%.
  • restenosis is considered to take place predominantly in the healing phase after coronary angioplasty and, using Tranilast, to require at least three months of treatment in order to show a therapeutic effect.
  • Tranilast could be efficaciously administered for the prevention or reduction of cardiovascular events associated with coronary intervention for a treatment period of less than three months.
  • the advantages of a shorter dosing protocol include: increased patient compliance, less total medication taken by the patient, reduced side effect profile and providing a more cost effective treatment.
  • Tranilast can be suitably administered in the prevention or reduction of cardiovascular events associated with coronary intervention for a period of less than three months.
  • This invention relates to a method for the prevention or reduction of cardiovascular events associated with coronary intervention in a mammal, particularly a human, which comprises administering to the subject N-(3',4'-dimethoxycinnamoyl)anthranilic acid (N-5 1 ) or a pharmaceutically acceptable salt thereof in a daily dose of from greater than 300 mg to about 1 ,200 mg for a treatment period of up to 89 days in association with coronary intervention.
  • inorganic salts such as sodium or calcium salt, or organic salts formed with amines such as morpholine, piperidine, arginine, and the like.
  • PTCA Percutaneous Transluminal Coronary Angioplasty
  • Directional Coronary Atherectomy and Stent placement can be included.
  • cardiovascular events is preferably meant myocardial infarction, death and the need for revascularization procedures associated with coronary intervention. Also included in the definition of "cardiovascular events” is a restenosis effect associated with coronary intervention.
  • prevention or reduction of cardiovascular events is meant that the incidence of myocardial infarction and/or death and/or the need for revascularization procedures associated with coronary intervention in Trailast treated patients are prevented or reduced in comparison to untreated patients. Also, the incidence of a restenosis effect is prevented or reduced in Trailast treated patients in comparison to untreated patients.
  • association with coronary intervention is meant that the treatment with Tranilast can commence immediately, for example within 4 to 8 hours, after coronary intervention, within a few days, for example 2 days, after coronary intervention or for a period of several days, for example about 7 days, prior to coronary intervention. Also contemplated within the term “in association with coronary intervention” is a dosing protocol in which a dose or several doses are skipped, for example in the morning of or on the day of coronary invention.
  • collected over the observation period means a period of up to 12 months.
  • the present invention relates to a method for the prevention or reduction of cardiovascular events associated with coronary intervention in a mammal, particularly a human, which comprises administering to the subject N-(3',4'- dimethoxycinnamoyl)anthranilic acid (N-5') (Tranilast) or a pharmaceutically acceptable salt thereof in a daily dose of from greater than 300 mg to about 1,200 mg for a treatment period of up to 89 days in association with coronary intervention.
  • N-5' N-(3',4'- dimethoxycinnamoyl)anthranilic acid
  • a pharmaceutically acceptable salt thereof in a daily dose of from greater than 300 mg to about 1,200 mg for a treatment period of up to 89 days in association with coronary intervention.
  • a preferred daily dosage amount of Tranilast for use in the present invention is about 400 mg to about 1,200 mg.
  • a more preferred daily dosage amount of Tranilast for use in the present invention is from about 500 mg to about 1,000 mg.
  • the most preferred daily dosage amount of Tranilast for use in the present invention is from about 600 mg to about 900 mg.
  • Particularly preferred is a daily dosage amount of about 600 mg of Tranilast for use in the present invention.
  • Particularly preferred is a daily dosage amount of about 900 mg of Tranilast for use in the present invention.
  • a preferred treatment period for use in the present invention is about 60 days in association with coronary intervention.
  • a more preferred treatment period for use in the present invention is about 45 days in association with coronary intervention.
  • the most preferred treatment period for use in the present invention is about 30 days in association with coronary intervention.
  • a preferred treatment period for use in the present invention is 14 days in association with coronary intervention.
  • a preferred method of use in the current invention is a method for preventing or reducing myocardial infarction associated with coronary intervention.
  • a preferred method of use in the current invention is a method for preventing or reducing death associated with coronary intervention.
  • a preferred method of use in the current invention is a method for preventing or reducing the need for revascularization procedures associated with coronary intervention.
  • a preferred method of use in the current invention is a method for preventing or reducing restenosis associated with coronary intervention.
  • the present invention therefor provides a method for the prevention or reduction of cardiovascular events associated with coronary intervention in a mammal, particularly a human, which comprises administering to the subject N-(3',4'- dimethoxycinnamoyl)anthranilic acid (N-5') (Tranilast) or a pharmaceutically acceptable salt thereof in a daily dose of from greater than 300 mg to about 1,200 mg for a treatment period of up to 89 days in association with coronary intervention.
  • N-5' N-(3',4'- dimethoxycinnamoyl)anthranilic acid
  • a pharmaceutically acceptable salt thereof in a daily dose of from greater than 300 mg to about 1,200 mg for a treatment period of up to 89 days in association with coronary intervention.
  • the invention also provides for the use of Tranilast or a pharmaceutically acceptable salt thereof in the prevention or reduction of cardiovascular events associated with coronary intervention in a mammal, particularly a human, in a daily dose of from greater than 300 mg to about 1,200 mg for a treatment period of up to 89 days in association with coronary intervention.
  • the invention also provides for a pharmaceutical composition for use in the prevention or reduction of cardiovascular events associated with coronary intervention in a mammal, particularly a human, which comprises Tranilast or a pharmaceutically acceptable salt thereof in a daily dose of from greater than 300 mg to about 1,200 mg for a treatment period of up to 89 days in association with coronary intervention.
  • Tranilast is generally described in United States Patent 3,940,422. Tranilast and pharmaceutically acceptable salts and compositions thereof can be readily prepared by known methods such as described in United States Patent 3,940,422.
  • Tranilast or a pharmaceutically acceptable salt thereof When Tranilast or a pharmaceutically acceptable salt thereof is employed therapeutically, it can be administered orally or parentally in appropriate dosage forms, such as powder, granules, tablets, capsules, injectable solutions, and the like.
  • a Tranilast pharmaceutical composition can be formulated by admixing suitable carriers such as excipients, disintegrators, binders, brighteners, and the like, and preparing in accordance with conventional molding methods and dosage forms.
  • a powdered dosage form can be formulated by admixing Tranilast or a pharmaceutically acceptable salt thereof with suitable excipients, binders, brighteners, and the like.
  • Tablets can be formulated by admixing Tranilast or a pharmaceutically acceptable salt thereof with suitable excipients, disintegrators, binders, brighteners, and the like, and compressing the mixture with conventional molding equipment.
  • the tablets also can be coated to provide film coated tablets, sugar-coated tablets, enteric-coated tablets, and the like.
  • Capsules can be formulated by admixing Tranilast or a pharmaceutically acceptable salt thereof thereof with suitable excipients, brighteners, and the like, and filling the mixture in capsules, or by forming granules containing Tranilast or a pharmaceutically acceptable salt thereof with conventional molding equipment, and filling the formed granules in capsules.
  • the daily dosage of Tranilast or a pharmaceutically acceptable salt thereof as an active ingredient will be an efficacious, nontoxic quantity selected from the range of from above 300 mg to about 1,200 mg of active compound, preferably from about 500 mg to about 1,000 mg of active compound, particularly preferred is a dosage of about 600 mg, particularly preferred is a dosage of about 900 mg, per adult patient preferably by oral administration for a treatment period of up to 89 days, preferably for about 60 days and most preferably for about 30 days in association with coronary intervention.
  • the dosage and term of administration can be changed depending upon the weight and age and sex of the patient, the severity of the condition to be treated, and the like.
  • the above indicated dose may be split and administered preferably from 1-6 times daily, preferably about 2 times a day, orally or parenterally.
  • Preferred forms of parenteral administration include topically, rectally, transdermally, by injection and continuously by infusion. Oral administration is preferred.
  • Optimal dosages to be administered may be readily determined by those skilled in the art, and will vary with the strength of the preparation, the mode of administration, and the advancement of the disease condition. Additional factors depending on the particular patient being treated will result in a need to adjust dosages, including patient age, weight, diet, and time of administration.
  • groups may also be given a calcium antagonist, nitrates and/or anti-platelet agents. These drugs are administered for 30 consecutive days after PTCA, and follow-up coronary angiography is performed within one year after PTCA.
  • the measurements are made in two projections and all measurements (before and immediately after PTCA and at final follow-up) are made in the same projection for more accurate comparisons.
  • Diameter stenosis is calculated as the mean of measurements, and restenosis is defined as a loss of at least 50% of the initial gain in luminal diameter accomplished by dilation or by 50% stenosis of a dilated vessel.
  • the comparative clinical data collected over the observation period demonstrate the efficacy of 30 days Tranilast treatment for the prevention or reduction of restenosis in patients after PTCA procedures.
  • groups may also be given a calcium antagonist, nitrates and/or anti-platelet agents. These drugs are administered for 30 consecutive days after PTCA.
  • the comparative clinical data collected over the observation period demonstrate the efficacy of 30 days Tranilast treatment for the prevention or reduction of incidence of myocardial infarction in patients after the PTCA procedure.
  • groups may also be given a calcium antagonist, nitrates and/or anti-platelet agents. These drugs are administered for 30 consecutive days after PTCA.
  • the comparative clinical data collected over the observation period demonstrate the efficacy of 30 days Tranilast treatment for the prevention or reduction of incidence of death in patients after PTCA procedures.
  • groups may also be given a calcium antagonist, nitrates and/or anti-platelet agents. These drugs are administered for 30 consecutive days after PTCA.
  • the comparative clinical data collected over the observation period demonstrate the efficacy of 30 days Tranilast treatment for the prevention or reduction for the need for revascularization procedures in patients after PTCA procedures.

Landscapes

  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

L'invention concerne une méthode de prévention ou réduction d'incidents cardio-vasculaires associés à une intervention coronarienne, chez un mammifère, notamment chez l'homme, cette méthode consistant à administrer à ce sujet un acide N-(3',4'-diméthoxycinnamoyl)anthranilique (N-5') ou un sel de celui-ci, acceptable sur le plan pharmacologique, en dose quotidienne comprise entre une quantité supérieure à 300 mg et environ 1200 mg, pendant une période pouvant couvrir jusqu'à 89 jours, en relation avec l'intervention coronarienne.
EP00904640A 1999-02-03 2000-02-02 Methode de prevention ou reduction d'incidents cardio-vasculaires associes a une intervention coronarienne Withdrawn EP1171116A4 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US11846299P 1999-02-03 1999-02-03
US118462P 1999-02-03
PCT/US2000/002622 WO2000045811A1 (fr) 1999-02-03 2000-02-02 Methode de prevention ou reduction d'incidents cardio-vasculaires associes a une intervention coronarienne

Publications (2)

Publication Number Publication Date
EP1171116A1 true EP1171116A1 (fr) 2002-01-16
EP1171116A4 EP1171116A4 (fr) 2004-11-17

Family

ID=22378750

Family Applications (1)

Application Number Title Priority Date Filing Date
EP00904640A Withdrawn EP1171116A4 (fr) 1999-02-03 2000-02-02 Methode de prevention ou reduction d'incidents cardio-vasculaires associes a une intervention coronarienne

Country Status (17)

Country Link
EP (1) EP1171116A4 (fr)
JP (1) JP2002536327A (fr)
KR (1) KR20010101934A (fr)
CN (1) CN1345237A (fr)
AU (1) AU2636600A (fr)
BR (1) BR0007921A (fr)
CA (1) CA2361581A1 (fr)
CO (1) CO5150206A1 (fr)
HK (1) HK1045104A1 (fr)
HU (1) HUP0200129A3 (fr)
IL (1) IL144721A0 (fr)
MX (1) MXPA01007835A (fr)
NO (1) NO20013788L (fr)
PL (1) PL351397A1 (fr)
TR (1) TR200102245T2 (fr)
WO (1) WO2000045811A1 (fr)
ZA (1) ZA200106353B (fr)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998029104A2 (fr) * 1996-12-30 1998-07-09 Kissei Pharmaceutical Co., Ltd. Utilisation d'acide 2-(3,4-dimethoxycinnamoyl)aminobenzoique dans la fabrication d'un medicament destine au traitement ou a la prevention de la restenose
EP0855387A1 (fr) * 1995-09-07 1998-07-29 Kissei Pharmaceutical Co., Ltd. Derives de 2-acylaminobenzamide, preventif et remede contre des maladies causees par une surmultiplication des cellules vasculaires de l'intima

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2617407B2 (ja) * 1992-09-14 1997-06-04 キッセイ薬品工業株式会社 血管内膜細胞過剰増殖疾患の予防および治療剤
US5693337A (en) * 1994-07-13 1997-12-02 Wakamoto Pharmaceutical Co., Ltd. Stable lipid emulsion

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0855387A1 (fr) * 1995-09-07 1998-07-29 Kissei Pharmaceutical Co., Ltd. Derives de 2-acylaminobenzamide, preventif et remede contre des maladies causees par une surmultiplication des cellules vasculaires de l'intima
WO1998029104A2 (fr) * 1996-12-30 1998-07-09 Kissei Pharmaceutical Co., Ltd. Utilisation d'acide 2-(3,4-dimethoxycinnamoyl)aminobenzoique dans la fabrication d'un medicament destine au traitement ou a la prevention de la restenose

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO0045811A1 *

Also Published As

Publication number Publication date
EP1171116A4 (fr) 2004-11-17
PL351397A1 (en) 2003-04-07
HK1045104A1 (zh) 2002-11-15
MXPA01007835A (es) 2002-04-24
HUP0200129A2 (hu) 2002-05-29
ZA200106353B (en) 2002-08-02
KR20010101934A (ko) 2001-11-15
BR0007921A (pt) 2002-09-10
CN1345237A (zh) 2002-04-17
HUP0200129A3 (en) 2003-06-30
NO20013788D0 (no) 2001-08-02
WO2000045811A1 (fr) 2000-08-10
JP2002536327A (ja) 2002-10-29
IL144721A0 (en) 2002-06-30
CA2361581A1 (fr) 2000-08-10
TR200102245T2 (tr) 2002-05-21
AU2636600A (en) 2000-08-25
CO5150206A1 (es) 2002-04-29
NO20013788L (no) 2001-09-28

Similar Documents

Publication Publication Date Title
US5385935A (en) Method for the inhibition of restenosis associated with coronary intervention
TW389696B (en) Accelerated release composition containing bromocriptine
RU2221563C2 (ru) Фармацевтическая композиция для лечения болезни паркинсона и синдромов паркинсона, способ ее получения, способ лечения болезни паркинсона и синдромов паркинсона
US20080021083A1 (en) 4-Methylpyrazole Formulations for Inhibiting Ethanol Intolerance
JPH02223521A (ja) 血清コレステロール低下剤
WO2000045811A1 (fr) Methode de prevention ou reduction d'incidents cardio-vasculaires associes a une intervention coronarienne
EP1180027A1 (fr) Methode de prevention ou de reduction d'incidents cardio-vasculaires associes a une intervention coronarienne
WO2001062241A1 (fr) Procede permettant de prevenir ou reduire les dysfonctionnements de l'acces vasculaire
WO2001097798A1 (fr) Procede servant a prevenir ou a reduire des evenements cardio-vasculaires induits par intervention coronarienne
KR100817932B1 (ko) 베르바민을 유효성분으로 포함하는 혈관 재협착 예방제
US20070254956A1 (en) Medicament for Therapeutic and/or Preventive Treatment of Restenosis or Reocclusion After Vascular Recanalization Operation
CA2465807A1 (fr) Methode de therapie du cancer
AU627277B2 (en) A method of treatment or prevention of post-ptca restenosis by post-ptca restenosis inhibitor
JP7498475B2 (ja) 多発性骨髄腫の治療剤
US20080139668A1 (en) Pharmaceutical composition for obovatol for the prevention and treatment of restenosis
US5354770A (en) Using imidazolyl tetrahydronaphthalene carboxylic acids to inhibit restenosis
HU212941B (en) Process for producing synergetic, antihypertensive pharmaceutical compositions containing verapamil and trandolapril
US20190262357A1 (en) Preventative or therapeutic agent for pulmonary hypertension including crude drug component
WO2002056941A2 (fr) Methode de traitement de l'acrosyndrome
EA042135B1 (ru) Таблетка деферипрона с отсроченным высвобождением и способ ее изготовления
JPH02289515A (ja) Ｐｔｃａ後の再狭窄抑制剤
JPH10287568A (ja) アルコール依存症治療剤

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 20010823

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AT BE CH CY DE DK ES FI FR GB GR IE IT LI LU MC NL PT SE

AX Request for extension of the european patent

Free format text: AL;LT;LV;MK;RO;SI PAYMENT 20010823

A4 Supplementary search report drawn up and despatched

Effective date: 20041005

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN

18D Application deemed to be withdrawn

Effective date: 20041223

REG Reference to a national code

Ref country code: HK

Ref legal event code: WD

Ref document number: 1045104

Country of ref document: HK