Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00058

2 Trial Registration Date

2005-09-09

i Registration Status

Retrospective

3 Secondary IDs

n/a

4 Source(s) of Funding

Schwarz Pharma (HK) Ltd

5 Primary Sponsor

Schwarz Pharma (HK) Ltd

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

Comparison of Lercanidipine with Felodipine in Essential Hypertension

10 Public Title

Comparison of Lercanidipine with Felodipine in Essential Hypertension

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?

2001-07-11

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Heart and Blood Vessel Diseases

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Lercanidipine

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

16 weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Felodipine

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

Patients with mild to moderate essential hypertension

ii Exclusion Criteria

Patients with uncontrolled hypertension or diabetes mellitus

iii Age Minimum

18

iv Age Maximum

75

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

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

2001-12-01

21 Target Sample Size

30

22 Recruitment Status

Complete

23 Primary Outcome

Changes in ambulatory blood pressure

24 Secondary Outcome

renal function, glucose and lipid profile, markers of oxidative stress

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

n/a

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Trial History Detail on 2009-11-27