Polypill and RiscOMeter to Prevent StrOke and CogniTive ImpairmEnt (PROMOTE)
Recruiting
Phase 3
Interventional Study
Stroke
Cognitive Decline
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 50 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 8,518 (estimated)
- Sponsor
- Hospital Moinhos de Vento · Other
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About This Trial
This study is a phase III, prospective, placebo-controlled randomized clinical trial involving 8,518 subjects with low to moderate stroke risk, followed for 3 years in Brazil. Participants will be randomized to receive either the polypill (valsartan 80 mg, amlodipine 5 mg, and rosuvastatin 10 mg), with dose adjustment of amlodipine to 2.5 mg for patients experiencing adverse events, or a placebo, …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* adults aged 50-75 years;
* no previous history of stroke, TIA or cardiovascular disease;
* systolic blood pressure (SBP) 121-139 mmHg;
* with one or more lifestyle risk factors: smoking, overweight (BMI\> 25 kg / m2), physical inactivity (WHO criteria for aerobic physical acti…
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