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SLCTR Registration Number
SLCTR/2007/012
Date of Registration
The date of last modification
Aug 05, 2012
View original TRDS
Scientific Title of Trial
The feasibility of a polypill clinical trial for primary prevention of cardiovascular disease (A pilot study)
Public Title of Trial
Polypill for cardiovascular prevention
Disease or Health Condition(s) Studied
Cardiovascular disease
Scientific Acronym
None
Public Acronym
None
Brief title
Polypill for cardiovascular prevention (P4C) study
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
1.WHO ethical approval: Under processing 2.Licence No to import drug: S-016715
What is the research question being addressed?
The feasibility of conducting a large scale polypill clinical trial for primary prevention of cardiovascular disease ?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy
Assignment
Parallel
Purpose
Study Phase
Intervention(s) planned
Intervention arm: Poplypill which is a combination of low dose aspirin, simvastatin, HCT and lisinopril control arm: usual care
Inclusion criteria
More than 40 years Estimated 10-year total CVD risk score ? 30%. (The total CVD risk assessment will be based on the recently developed WHO CVD risk prediction charts) No contraindication for treatment with aspirin, angiotensin converting enzyme inhibitors, low-dose diuretics, or statins. Informed consent given
Exclusion criteria
Patients with established angina pectoris, coronary heart disease, myocardial infraction, transient ischemic attacks, stroke, peripheral vascular disease, coronary revascularization and /or carotid endarterectomy Left ventricular hypertrophy (on ECG) or hypertensive retinopathy (grade three or four) Patients with secondary hypertension Patients with diabetes type 1 or 2 with overt neuropathy or other significant renal disease Known renal failure or impairment Atrial fibrillation ALT > 1.5 times the upper limit of normal History of liver cirrhosis or hepatitis History of recent gastrointestinal bleeding (within the last year) Women of child bearing age History of life-limiting diseases or events Unwillingness to sign informed consent
Primary outcome(s)
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1.
-Reduction in the estimated 10 year cardiovascular risk -Adherence to the study medication throughout the study (3 months) -Tolerability (the proportion of participants who withdraw due to side effects |
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Secondary outcome(s)
|
1.
â¢Acceptability of the polypill by physicians and patients â¢Introducing the newly developed WHOcardiovascular risk prediction charts â¢Improving the knowledge of participants to theircardiovascular risk factors â¢Building an infrastructure for internationalcollaborative research in cardiovascular disease |
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Target number/sample size
120
Countries of recruitment
Malawi, Sri Lanka
Anticipated start date
2008-11-06
Anticipated end date
2008-04-30
Date of first enrollment
Date of study completion
Recruitment status
Complete
Funding source
World Health Organization Headquarter Department of Chronic Diseases and Health Promotion (CHP), Geneva, Switzerland-partial fund Wake Forest University School of Medicine Division of Public Health Sciences, Winston Salem NC, USA Dr Reddyâs laboratories l
Regulatory approvals
Status
Date of Approval
Approval number
Details of Ethics Review Committee
| Name: | |
| Institutional Address: | |
| Telephone: | |
| Email: |
Contact person for Scientific Queries/Principal Investigator
Curt D. Furberg MD PhD
Professor
Division of Public Health Sciences, Wake Forest
University School of Medicine
Wachovia (WC), Room Number:2346
Medical Center Blvd.
Winston-Salem, North Carolina 27157-1063
336-716-3730
cfurberg@wfubmc.edu
Contact Person for Public Queries
Dr. Padma Gunaratne
Consultant Neurologist
No 24, Sulaiman Terrace, Colombo 5
0773170789
pagunara@hotmail.com
Primary study sponsor/organization
World Health Organization Headquarter
Wake Forest University School of Medicine
Department of Chronic Diseases and Health
Promotion(CHP), Geneva, Switzerland
Division of Public Health Sciences
Wachovia (WC), Room Number: 2346
336-716-3730
mendiss@who.int, cfurberg@wfubmc.edu
http://www.who.int/cardiovascular_diseases/en/ http://www.phs.wfubmc.edu/web/public/programs.cfm
Secondary study sponsor (If any)
Dr Reddyâs laboratories limited
7-1-27 Ameerpet, Hyderabad 500 016. INDIA
91-40-3731946
91-40-3731955
raghucidambi@drreddys.com
http://www.drreddys.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
