Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00063

2 Trial Registration Date

2005-09-12

i Registration Status

Retrospective

3 Secondary IDs

n/a

4 Source(s) of Funding

N/A

5 Primary Sponsor

Roche

6 Secondary Sponsor

n/a

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Benny Fok

ii Address

Department of Medicine and Therapeutics

iii Phone

26323377

iv Email

bfok@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Brian Tomlinson

ii Address

Department of Medicine and Therapeutics

iii Phone

26323139

iv Email

btomlinson@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

A placebo controlled, randomized study to examine the impact of 24-week orlistat treatment on postprandial triglyceridaemia, steatohepatitis and cardiovascular risk factors in overweight Chinese patients

10 Public Title

A placebo controlled, randomized study to examine the impact of 24-week orlistat treatment on postprandial triglyceridaemia, steatohepatitis and cardiovascular risk factors in overweight Chinese patients

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

n/a

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2003-11-04

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Obesity

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Orlistat

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

24 weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Placebo

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Chinese patients with obesity and dyslipidaemia

ii Exclusion Criteria

Patients on orlistat within one month prior to study

iii Age Minimum

18

iv Age Maximum

78

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2004-01-01

21 Target Sample Size

40

22 Recruitment Status

Complete

23 Primary Outcome

Postprandial triglyceridaemia, visceral and hepatic fat deposition

24 Secondary Outcome

Body weight, cardiovascular risk profiles

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2009-11-27

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000655

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

n/a

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Trial History Detail on 2011-02-08