Official Title: “Phase II Study of Heart Polypill in Primary Prevention of Cardiovascular Disease - Safety and Efficacy”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2008

Intervention(s) in this Clinical Trial

• 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
• Drug: Placebo
  • Placebo Tablet. once every morning

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Heart polypill Tablet (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)
• Placebo Comparator: 2
  • Placebo drug will be given randomly to this arm of the study

Primary Measures

• Reduction of the mortality/morbidity due to cardiovascular disease, adverse drug reaction and adherence by heart polypill
  • Time Frame: one year
    Safety Issue?: Yes

Secondary Measures

• Patients' and physicians acceptability of heart polypill
  • Time Frame: one year
    Safety Issue?: Yes

Inclusion Criteria:

• 1. Men's with the age between 50 to 80 and women with the age between 60 to 80
• 2. Participants have not been administered for any anti-hypertensive drug recently.
• 3. Participants have not been administered for any diuretic drug.
• 4. There are no contraindications for administration of thiazide diuretics (allergic reaction or gout)
• 5. Participants should have systolic blood pressure between 100 to 140 mmHg
• 6. Participants should have diastolic blood pressure between 60 to 90 mmHg
• 7. Decline in systolic blood pressure should not be over 10 mmHg

Excluding criteria:

• 1. Administration of one of the component of polypill.
• 2. Use of any anti-hypertensive drugs
• 3. Use of aspirin
• 4. Use of statin
• 5. Existence of contraindication for any component of poly pill.
• 6. Existence of history for allergic reaction after administration of aspirin.
• 7. Existence of active peptic ulcers for recent 2 years
• 8. Any liver disease
• 9. Systolic blood pressure<100mmHg and diastolic pressure <70 mmHg
• 10. Existence of symptomatic orthostatic hypotension
• 11. Existence of hyperuricemia or gout

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Tehran University of Medical Sciences

Overall Clinical Trial Officials and Contacts

Reza Malekzadeh, M.D. Principal Investigator Tehran University of Medical Sciences  

Overall Contact: Mansoor Rastegarpanah, Ph.D. +98912-125-5960 rastegar@sina.tums.ac.ir

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00603590

Study ID Number: 301/148

ClinicalTrials.gov Identifier: NCT00603590

Health Authority: Iran: Ministry of Health