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

4 Source(s) of Funding

N/A

5 Primary Sponsor

Roche

6 Secondary Sponsor

Function

Please specify

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

i Name

Benny Fok

ii Address

iii Phone

iv Email

email bfok@cuhk.edu.hk

v Affiliation

vi Country

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

i Name

Brian Tomlinson

ii Address

iii Phone

iv Email

email btomlinson@cuhk.edu.hk

v Affiliation

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

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

12 Countries of Recruitment

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

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

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

Not Yet Recruiting

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

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

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Trial History Detail on 2009-11-19