Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000108415
Ethics application status
Approved
Date submitted
10/06/2006
Date registered
7/02/2007
Date last updated
7/02/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
An antihypertensive intervention trial to lower blood pressure in untreated hypertensive patients based on the gene polymorphisms in the pathway of the drug-metabolism and biological effects
Scientific title
Antihypertensive effects and side effects of Atenolol, Captopril, Nifidipine Sustained Release and Hydrochlorothiazide relative to the gene polymorphisms in untreated hypertensive patients in Rural China
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 1602 0
Condition category
Condition code
Cardiovascular 1705 1705 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1: Single tablet orally taken twice daily, 12.5 and 25 milligrams of Hydrochlorothiazide.
Group 2: Single tablet, twice daily, 12.5 and 25 milligrams of Atenolol.
Group 3: Single tablet, twice daily, 20 and 40 milligrams of Nifedipine Sustained Release
Group 4: Single tablet, twice daily, 25 and 50 milligrams of Captopril.
All interventions were for eight weeks. Patients were first treated with lower dosage; if their blood pressure was still above 140/90 mmHg after two weeks, the dosage was increased to the second higher dosage.
Intervention code [1] 1135 0
Treatment: Drugs
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 2373 0
Office blood pressure reponse
Timepoint [1] 2373 0
From baseline to 8 weeks, including measurement at 2 and 4 weeks.
Secondary outcome [1] 4126 0
Side effects were observed at 2 weeks and 4 weeks after drug treatment.
Timepoint [1] 4126 0

Eligibility
Key inclusion criteria
Untreated hypertensive patients, including those with newly diagnosed hypertension ( systolic/diastolic blood pressure >=160/95mmHg at two visits), and those with history of hypertension but not receiving antihypertensive treatment for at least 8 weeks (systolic/diastolic blood pressure >=140/90mmHg at two visits).
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Secondary hypertension; contraindication to any studied drugs; serum potassium values<3.5mEq/L or >5.5mEq/L at screening stage; requirement for any study drugs for reasons other than hypertension; low likelihood of compliance with protocol (eg, dementia, substance abuse); and a history of any severe, life-threatening disease within the past 3 years.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealed randomisation with sequential study numbers given to subjects and then allocation of pre-filled numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random permuted blocks by a person not involved with subjects (A total of 4 blocks)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Both doctors and patients were blinded to drug name.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/03/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
4000
Accrual to date
Final
Recruitment outside Australia
Country [1] 353 0
China
State/province [1] 353 0

Funding & Sponsors
Funding source category [1] 1851 0
Government body
Name [1] 1851 0
the Ministry of Science and Technology of China
Country [1] 1851 0
China
Primary sponsor type
Other
Name
Cardiovascular Institute, Chinese Academy of Medical Sciences
Address
Country
China
Secondary sponsor category [1] 1666 0
Individual
Name [1] 1666 0
Professor Rutai Hui
Address [1] 1666 0
Country [1] 1666 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3457 0
Fuwai Hosptial, Chinese Academy of Medical Sciences
Ethics committee address [1] 3457 0
Ethics committee country [1] 3457 0
China
Date submitted for ethics approval [1] 3457 0
Approval date [1] 3457 0
28/10/2004
Ethics approval number [1] 3457 0
2004032
Ethics committee name [2] 3458 0
The Fourth Hospital of Xinyang
Ethics committee address [2] 3458 0
Henan province
Ethics committee country [2] 3458 0
China
Date submitted for ethics approval [2] 3458 0
Approval date [2] 3458 0
02/11/2004
Ethics approval number [2] 3458 0
2004015

Summary
Brief summary
Hypertension is an important public health problem. The inter-individual clinical response to antihypertensive therapy is highly variable. Genetic variations may influence the clinical response to antihypertensive treatment and side effects. This double-blind, active-controlled randomized trial was aimed to investigate the association between polymorphisms of candidate genes and blood pressure response to antihypertensive drugs in untreated hypertensive patients in countryside Chinese. All study medications were identical in appearance. The code was used to conceal drug name. The drugs were distributed to four groups according to predetermined number of each block.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35444 0
Address 35444 0
Country 35444 0
Phone 35444 0
Fax 35444 0
Email 35444 0
Contact person for public queries
Name 10324 0
Professor Rutai Hui
Address 10324 0
Fuwai Hospital
167 Bei Li Shi Lu
Xi Cheng District Beijing 100037
Country 10324 0
China
Phone 10324 0
+86 0168333902
Fax 10324 0
+86 0168331730
Email 10324 0
[email protected]
Contact person for scientific queries
Name 1252 0
Professor Rutai Hui
Address 1252 0
Fuwai Hospital
167 Bei Li Shi Lu
Xi Cheng District Beijing 100037
Country 1252 0
China
Phone 1252 0
+86 0168333902
Fax 1252 0
+86 0168331730
Email 1252 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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