Phase II Study of Heart Polypill Safety and Efficacy in Primary Prevention of Cardiovascular Disease

This study has been completed.

Study NCT00603590 Information provided by Tehran University of Medical Sciences

First Received on January 1, 2008. Last Updated on September 22, 2009 History of Changes

Results First Received: April 13, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Conditions:	Cardiovascular Disease Hypertension Hyperlipidemia Heart Disease
Interventions:	Drug: Polypill Drug: Placebo drug

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between July 2006 and January 2007, 1,733 subjects attended the Kalaleh heart clinic. Of those assessed 872 were included in the run-in phase of the study. Of these 475 were randomized.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
872 subjects entered the run in phase, 258 were excluded. Most exclusions were due to laboratory test results. 614 completed the run-in phase of the study, 65 were excluded. Most were excluded because they did not attend the clinic. Of 549 subjects remaining, 74 were not randomized. 475 subjects who were randomized.

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

872 subjects entered the run in phase, 258 were excluded. Most exclusions were due to laboratory test results.

614 completed the run-in phase of the study, 65 were excluded. Most were excluded because they did not attend the clinic.

Of 549 subjects remaining, 74 were not randomized.

475 subjects who were randomized.

Reporting Groups

	Description
Polypill	Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)
Control	Identical placebo tablet

Participant Flow: Overall Study

	Polypill	Control
STARTED	241	234
One Month	204	212
Four Months	187	200
Eight Months	178	194
COMPLETED	165	183
NOT COMPLETED	76	51
Did not attend study clinic	39	30
Refused blood test	5	1
Patient discontinued study drug	22	15
Adverse Event	2	0
Lost to Follow-up	8	4
Cardiovascular event	0	1

Baseline Characteristics

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Reporting Groups

	Description
Polypill	Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)
Control	Identical placebo tablet

Baseline Measures

	Polypill	Control	Total
Number of Participants [units: participants]	241	234	475
Age [units: Years] Mean ± Standard Deviation	59.0 ± 6.5	59.1 ± 7.3	59.0 ± 6.9
Gender [units: participants]
Female	91	67	158
Male	150	167	317
Region of Enrollment [units: participants]
Iran, Islamic Republic of	241	234	475
Diastolic Blood Pressure ^[1] [units: mm Hg] Mean ± Standard Deviation	78.4 ± 10.4	81.2 ± 9.7	79.8 ± 10.1
LDL cholesterol ^[2] [units: mg/dL] Mean ± Standard Deviation	116.7 ± 25.8	116.6 ± 24.8	116.6 ± 25.2
Systolic Blood Pressure ^[3] [units: mm Hg] Mean ± Standard Deviation	124.8 ± 17.3	130.3 ± 17.4	127.5 ± 17.5

[1]	Mean of two seated blood presures
[2]	Serum LDL cholesterol levels
[3]	Mean of two seated systolic blood pressures

Outcome Measures

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1. Primary:

Systolic Blood Pressure [ Time Frame: One year ]

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2. Secondary:

Diastolic Blood Pressure [ Time Frame: One year ]

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3. Secondary:

LDL Cholesterol [ Time Frame: One year ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Incomplete follow up Because of differences in systolic blood pressure at baseline, final analysis will take account of baseline differences

Results Point of Contact:

Name/Title: Mansoor Rastegarpanah
Organization: Tehran University of Medical Sciences
phone: +989121255960
e-mail: rastegar@sina.tums.ac.ir

Publications:

Rastegarpanah M, Malekzadeh F, Thomas GN, Mohagheghi A, Cheng KK, Marshall T. A new horizon in primary prevention of cardiovascular disease, can we prevent heart attack by "heart polypill"? Arch Iran Med. 2008 May;11(3):306-13. No abstract available.

Responsible Party:	Reza Malekzadeh, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00603590 History of Changes
Other Study ID Numbers:	301/148, CCT-NAPN 15388
Study First Received:	January 1, 2008
Results First Received:	April 13, 2009
Last Updated:	September 22, 2009
Health Authority:	Iran: Ministry of Health