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Phase II Study of Heart Polypill Safety and Efficacy in Primary Prevention of Cardiovascular Disease
This study is currently recruiting participants.
Verified by Tehran University of Medical Sciences, April 2008
Sponsors and Collaborators: Tehran University of Medical Sciences
University Hospital Birmingham
Information provided by: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00603590
  Purpose

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
Cardiovascular Disease
Hypertension
Hyperlipidemia
Heart Disease
Drug: Heart polypill (Atorvastatin, Asprin, Enalapril, Hydrochlorothiazide)
Drug: Placebo
Phase II

MedlinePlus related topics: Heart Diseases High Blood Pressure Vascular Diseases
Drug Information available for: Atorvastatin Atorvastatin calcium Hydrochlorothiazide Acetylsalicylic acid Enalapril Enalapril maleate Enalaprilat
U.S. FDA Resources
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

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Reduction of the mortality/morbidity due to cardiovascular disease, adverse drug reaction and adherence by heart polypill [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Patients' and physicians acceptability of heart polypill [ Time Frame: one year ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603590

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

Locations
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    
Sponsors and Collaborators
Tehran University of Medical Sciences
University Hospital Birmingham
Investigators
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
  More Information

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

Keywords provided by Tehran University of Medical Sciences:
Cardiovascular disease
primary prevention
Polypill
efficacy
safety
ADR
Diabetes
Adherence
Compliance

Study placed in the following topic categories:
Heart Diseases
Hyperlipidemias
Metabolic Diseases
Diabetes Mellitus
Vascular Diseases
Hydrochlorothiazide
Enalapril
Enalaprilat
Aspirin
Metabolic disorder
Dyslipidemias
Atorvastatin
Hypertension
Lipid Metabolism Disorders

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 14, 2009