Trial Outcomes & Findings for Phase II Study of Heart Polypill Safety and Efficacy in Primary Prevention of Cardiovascular Disease (NCT NCT00603590)

NCT ID: NCT00603590

Last Updated: 2009-10-02

Results Overview

Systolic blood pressure. Mean of two seated measurements.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 475 participants
• Primary outcome timeframe: One year
• Results posted on: 2009-10-02

Participant Flow

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.

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.

Participant milestones

Measure	Polypill Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)	Control Identical placebo tablet
Overall Study STARTED	241	234
Overall Study One Month	204	212
Overall Study Four Months	187	200
Overall Study Eight Months	178	194
Overall Study COMPLETED	165	183
Overall Study NOT COMPLETED	76	51

Reasons for withdrawal

Measure	Polypill Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)	Control Identical placebo tablet
Overall Study Did not attend study clinic	39	30
Overall Study Refused blood test	5	1
Overall Study Patient discontinued study drug	22	15
Overall Study Adverse Event	2	0
Overall Study Lost to Follow-up	8	4
Overall Study Cardiovascular event	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Polypill n=241 Participants Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)	Control n=234 Participants Identical placebo tablet	Total n=475 Participants Total of all reporting groups
Age Continuous	59.0 Years STANDARD_DEVIATION 6.5 • n=5 Participants	59.1 Years STANDARD_DEVIATION 7.3 • n=7 Participants	59.0 Years STANDARD_DEVIATION 6.9 • n=5 Participants
Sex: Female, Male Female	91 Participants n=5 Participants	67 Participants n=7 Participants	158 Participants n=5 Participants
Sex: Female, Male Male	150 Participants n=5 Participants	167 Participants n=7 Participants	317 Participants n=5 Participants
Region of Enrollment Iran, Islamic Republic of	241 participants n=5 Participants	234 participants n=7 Participants	475 participants n=5 Participants
Diastolic Blood Pressure	78.4 mm Hg STANDARD_DEVIATION 10.4 • n=5 Participants	81.2 mm Hg STANDARD_DEVIATION 9.7 • n=7 Participants	79.8 mm Hg STANDARD_DEVIATION 10.1 • n=5 Participants
LDL cholesterol	116.7 mg/dL STANDARD_DEVIATION 25.8 • n=5 Participants	116.6 mg/dL STANDARD_DEVIATION 24.8 • n=7 Participants	116.6 mg/dL STANDARD_DEVIATION 25.2 • n=5 Participants
Systolic Blood Pressure	124.8 mm Hg STANDARD_DEVIATION 17.3 • n=5 Participants	130.3 mm Hg STANDARD_DEVIATION 17.4 • n=7 Participants	127.5 mm Hg STANDARD_DEVIATION 17.5 • n=5 Participants

PRIMARY outcome

Timeframe: One year

Population: Intention to treat Results shown here are based on 12 month observation. Analysis for final paper will be last observation carried forward

Systolic blood pressure. Mean of two seated measurements.

Outcome measures

Measure	Polypill n=165 Participants Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)	Control n=183 Participants Identical placebo tablet
Systolic Blood Pressure	121.7 mm Hg Standard Deviation 16.8	129.7 mm Hg Standard Deviation 18.3

SECONDARY outcome

Timeframe: One year

Population: Analysis by intention to treat. Results shown here are based on 12 month observation. Analysis for final paper will be last observation carried forward.

Mean of two seated diastolic blood pressures

Outcome measures

Measure	Polypill n=165 Participants Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)	Control n=183 Participants Identical placebo tablet
Diastolic Blood Pressure	77.6 mm Hg Standard Deviation 10.6	81.3 mm Hg Standard Deviation 11.1

SECONDARY outcome

Timeframe: One year

Population: Intention to treat Results shown here are based on 12 month observation. Analysis for final paper will be last observation carried forward

Serum LDL cholesterol

Outcome measures

Measure	Polypill n=160 Participants Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)	Control n=175 Participants Identical placebo tablet
LDL Cholesterol	87.8 mg/dL Standard Deviation 26.7	112.0 mg/dL Standard Deviation 26.8

Adverse Events

Polypill

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Control

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Polypill Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)	Control Identical placebo tablet
Cardiac disorders Cardiovascular event	0.00% 0/241	0.43% 1/234 • Number of events 1

Other adverse events

Measure	Polypill Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)	Control Identical placebo tablet
Respiratory, thoracic and mediastinal disorders Cough	0.83% 2/241 • Number of events 2	0.00% 0/234

Additional Information

Mansoor Rastegarpanah

Tehran University of Medical Sciences

Phone: +989121255960

Email: rastegar@sina.tums.ac.ir

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place