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Sponsors and Collaborators: |
Tehran University of Medical Sciences University Hospital Birmingham |
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Information provided by: | Tehran University of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT00603590 |
The cardio vascular diseases are the main cause of death all around the world. About 45% of the death in Iran relates to this disease. We therefore aimed to establish whether use of evidence-based combination drug regimens such as polypill is efficacious and safe to use in primary prevention. There are some studies, which established that four effective medicines in one tablet had a better compliance of the patients and had fewer side effects.
Methods:
The first double blind clinical research was designed to study morbidity and mortality in 2 groups of patients in a randomized manner 500 healthy volunteers and will be followed up for 1 year. One group will take a tablet of polypill, which contain three types of medicine effective in cardio vascular disease. This tablet contains a drug of preventing platelet aggregation aspirin (81mg), two drugs of reducing blood pressure containing ACE inhibitor enalapril (2.5mg) and one diuretic drug such as hydrochlorothiazide (12.5mg) and one reducing hyperlipidemia from the group of Statins Atorvastatin (20mg) and in the other group will take placebo.
Condition | Intervention | Phase |
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Cardiovascular Disease Hypertension Hyperlipidemia Heart Disease |
Drug: Heart polypill (Atorvastatin, Asprin, Enalapril, Hydrochlorothiazide) Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of Heart Polypill in Primary Prevention of Cardiovascular Disease - Safety and Efficacy |
Estimated Enrollment: | 500 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | June 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Heart polypill Tablet (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)
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Drug: Heart polypill (Atorvastatin, Asprin, Enalapril, Hydrochlorothiazide)
Heart polypill tablet(Atorvastatin 20 mg, Aspirin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg) once every morning
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2: Placebo Comparator
Placebo drug will be given randomly to this arm of the study
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Drug: Placebo
Placebo Tablet. once every morning
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Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Excluding criteria:
Contact: Mansoor Rastegarpanah, Ph.D. | +98912-125-5960 | rastegar@sina.tums.ac.ir |
Iran, Islamic Republic of, Golestan | |
Kalaleh Heart Study Center | Recruiting |
Kalaleh, Golestan, Iran, Islamic Republic of | |
Contact: Fatemeh Malekzadeh, M.D. +9821 Fmalek@ams.ac.ir |
Principal Investigator: | Reza Malekzadeh, M.D. | Tehran University of Medical Sciences |
Study Director: | Fatemeh Malekzadeh, M.D. | Tehran University of Medical Sciences |
Study Chair: | Akram Pourshams, M.D. | Tehran University of Medical Sciences |
Principal Investigator: | Mansoor Rastegarpanah, Ph.D. | Tehran University of Medical Sciences |
Responsible Party: | Tehran University of Medical Sciences ( Reza Malekzadeh ) |
Study ID Numbers: | 301/148, CCT-NAPN 15388 |
Study First Received: | January 1, 2008 |
Last Updated: | April 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00603590 |
Health Authority: | Iran: Ministry of Health |
Cardiovascular disease primary prevention Polypill efficacy safety |
ADR Diabetes Adherence Compliance |
Heart Diseases Hyperlipidemias Metabolic Diseases Diabetes Mellitus Vascular Diseases Hydrochlorothiazide Enalapril |
Enalaprilat Aspirin Metabolic disorder Dyslipidemias Atorvastatin Hypertension Lipid Metabolism Disorders |
Antimetabolites Molecular Mechanisms of Pharmacological Action Antilipemic Agents Diuretics Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Enzyme Inhibitors Anticholesteremic Agents Cardiovascular Agents |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Antihypertensive Agents Pharmacologic Actions Protease Inhibitors Membrane Transport Modulators Natriuretic Agents Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases |