Home » Trials » SLCTR/2007/012


The feasibility of a polypill clinical trial for primary prevention of cardiovascular disease (A pilot study) -

SLCTR Registration Number

SLCTR/2007/012


Date of Registration

19 Oct 2007

The date of last modification

Apr 01, 2013


View original TRDS


Trial Status



Application Summary


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 of Health Condition(s) Studied

Cardiovascular disease


Scientific Acronym

None


Public Acronym

None


Brief title

Polypill for cardiovascular prevention (P4C) study


Universal Trail 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


Trial Details


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


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)

-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


Primary outcome(s) - Time of assessment(s)


Secondary outcome

•Acceptability of the polypill by physicians and patients •Introducing the newly developed WHOcardiovascular risk prediction charts •Improving the knowledge of participants to theircardiovascular risk factors •Building an infrastructure for internationalcollaborative research in cardiovascular disease


Secondary outcome(s) - Time of assessment(s)

•Acceptability of the polypill by physicians and patients •Introducing the newly developed WHOcardiovascular risk prediction charts •Improving the knowledge of participants to theircardiovascular risk factors •Building an infrastructure for internationalcollaborative research in cardiovascular disease



Target number/sample size

200


Countries of recruitment

Malawi, Sri Lanka


Anticipated start date

2008-11-06


Anticipated end date

2008-04-30


Recruitment status

Complete


State of ethics review approval

Approved by the Ethics Review Committee of the National Hospital of Sri Lanka


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 Reddy’s laboratories l



Contact & Sponsor Information


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 Reddy’s laboratories limited

7-1-27 Ameerpet, Hyderabad 500 016. INDIA
91-40-3731946
91-40-3731955
raghucidambi@drreddys.com
http://www.drreddys.com