Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000109404
Ethics application status
Approved
Date submitted
25/06/2006
Date registered
7/02/2007
Date last updated
7/02/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Stroke Prevention by Antihypertensive Drugs (SPREAD) Trial
Scientific title
An Antihypertensive Trial to Prevent Stroke with Hydrochlorothiazide combined with Atenolol as required and Nifedipine Sustained Release combined with Captopril as required in patients with hypertension from rural China.
Universal Trial Number (UTN)
Trial acronym
SPREAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 1603 0
Condition category
Condition code
Cardiovascular 1706 1706 0 0
Hypertension
Stroke 1707 1707 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1) Hydrochlorothiazide (single tablet orally taken twice daily, 12.5 or 25 milligrams) based combinations with Atenolol (single tablet, orally, 12.5 or 25 milligrams, twice daily);
2) Nifedipine Sustained Release (single tablet, orally taken, 20 or 40 milligrams, twice daily) based combinations with Captopril (single tablet, orally, 25 or 50 milligrams, twice daily);
Check the compliance for antihypertensive drugs once a month.

All interventions were for two years. 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; if their blood pressure was still above 140/90 mmHg after four weeks, Hydrochlorothiazide based group combined with Atenolol while the Nifedipine Sustained Release based group combined with Captopril.
Intervention code [1] 1163 0
Treatment: Drugs
Comparator / control treatment
3) Hypertensive controls: Check the compliance for antihypertensive treatment once every 2 years, no placebo control.
Control group
Active

Outcomes
Primary outcome [1] 2374 0
Office blood pressure response from baseline to 2 years
Timepoint [1] 2374 0
At 2 years
Primary outcome [2] 2375 0
Target organ damage: left ventricular hypertrophy (LVH), renal dysfunction (serum creatinine level, microalbuminuria)
Timepoint [2] 2375 0
At 2 years
Primary outcome [3] 2376 0
New onset diabetes
Timepoint [3] 2376 0
At 2 years
Primary outcome [4] 2377 0
Metabolic alternations
Timepoint [4] 2377 0
At 2 years
Primary outcome [5] 2378 0
Cardiovascular events including all causes of death, myocardial infarction, stroke, and heart faiture
Timepoint [5] 2378 0
At 2 years
Secondary outcome [1] 4127 0
Office blood pressure response
Timepoint [1] 4127 0
From baseline to 6 month, 12 month, 18 month and 24 month.

Eligibility
Key inclusion criteria
Hypertensive patients, including untreated hypertensive patients (systolic/diastolic blood pressure >=140/90mmHg at two visits), and treated hypertensive patients (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; controindications to any study 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
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealed randomization 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 3 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
Active, not recruiting
Date of first participant enrolment
Anticipated
28/05/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6000
Accrual to date
Final
Recruitment outside Australia
Country [1] 361 0
China
State/province [1] 361 0

Funding & Sponsors
Funding source category [1] 1852 0
Government body
Name [1] 1852 0
the Ministry of Science and Technology of China
Country [1] 1852 0
China
Primary sponsor type
Other
Name
Cardiovascular Institute, Chinese Academy of Medical Sciences
Address
Country
China
Secondary sponsor category [1] 1667 0
Individual
Name [1] 1667 0
Professor Rutai Hui
Address [1] 1667 0
Country [1] 1667 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3459 0
Fuwai Hosptial, Chinese Academy of Medical Sciences
Ethics committee address [1] 3459 0
Ethics committee country [1] 3459 0
China
Date submitted for ethics approval [1] 3459 0
Approval date [1] 3459 0
28/10/2004
Ethics approval number [1] 3459 0
2004032
Ethics committee name [2] 3460 0
The Fourth Hospital of Xinyang
Ethics committee address [2] 3460 0
Ethics committee country [2] 3460 0
China
Date submitted for ethics approval [2] 3460 0
Approval date [2] 3460 0
02/11/2004
Ethics approval number [2] 3460 0
2004015

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35292 0
Address 35292 0
Country 35292 0
Phone 35292 0
Fax 35292 0
Email 35292 0
Contact person for public queries
Name 10352 0
Prof Rutai Hui
Address 10352 0
FuWai Hospital
167 Beilishilu
Beijing
Country 10352 0
China
Phone 10352 0
+860168333902
Fax 10352 0
+860168331730
Email 10352 0
[email protected]
Contact person for scientific queries
Name 1280 0
Prof Rutai Hui
Address 1280 0
FuWai Hospital
167 Beilishilu
Beijing
Country 1280 0
China
Phone 1280 0
+860188398631
Fax 1280 0
+860168331730
Email 1280 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.