Effect of a Polypill on middle-aged and elderly Iranians

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN43076122

Enrollment

500

Registered

2006-10-19

Start date

2006-10-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular disease in middle-aged and older adults. Circulatory System Cardiovascular disease

Interventions

Current interventions as of 08/09/2008: A combination therapy (polypill) consisting of aspirin 81 mg, hydrochlorothiazide 12.5 mg, enalapril 2.5 mg and atorvastatin 20 mg or an identical placebo. Pl

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Men between the ages of 50 and 80 (inclusive) 2. Women aged 55 to 80 (inclusive) 3. Living in Kalaleh 4. Free from existing cardiovascular disease (stroke, Transient Ischaemic Attack [TIA], Myocardial Infarction [MI], or angina) 5. Not currently be taking or eligible for antihypertensive treatment, aspirin or statins

Exclusion criteria

Exclusion criteria: 1. Total cholesterol levels exceed 240 mg/dL 2. Blood pressure exceeds 160/100 mmHg at baseline 3. People with existing vascular disease 4. Clear indication or contra-indication for any component of the polypill or other chronic medical problems that would interfere with participation

Design outcomes

Primary

Measure	Time frame
Combined cardiovascular events (MI, new onset angina, coronary artery surgery, stroke or sudden cardiac death)	—

Secondary

Measure	Time frame
1. Total mortality 2. Gastrointestinal bleeding	—

Countries

Iran

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026