Single Pill to Avert Cardiovascular Events (SPACE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01313702|
Recruitment Status : Unknown
Verified March 2012 by Hospital do Coracao.
Recruitment status was: Not yet recruiting
First Posted : March 14, 2011
Last Update Posted : March 16, 2012
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Disease||Drug: polipillV1 Drug: polipillV2 Drug: usual care||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effect of Polipill on Patients at High Cardiovascular Risk : a Randomized Controlled Trial|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||April 2014|
|Estimated Study Completion Date :||July 2014|
poli pill version 1: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, atenolol 50mg
polipill version 1: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, atenolol 50mg
Other Name: no other name
Polipill versão2: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, hydrochlorothiazide 12.5mg.
Polipill version 2: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, hydrochlorothiazide 12.5mg.
Other Name: no other name
|Active Comparator: usual care||
Drug: usual care
the drugs used in clinical practice, defined by physician
- compliance with treatment [ Time Frame: 18 months ]
- changed in blood pressure [ Time Frame: 18 months ]
- changes in LDL-cholesterol levels [ Time Frame: 18 months ]
- the main reason for non compliance with treatment [ Time Frame: 18 months ]
- safety of poli pill measures by laboratorial tests [ Time Frame: 18 months ]hemogram and blood platelets count, liver function tests (ALT, AST), renal function tests (creatinine).
- combined outcome [ Time Frame: 18 months ]compound of cardiovascular and total mortality, major cardiovascular events and cholesterol levels.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01313702
|Contact: Otavio Berwanger, PhD||+55 11 30536611 ext firstname.lastname@example.org|
|Instituto de Ensino e Pesquisa - IEP - HCor||Not yet recruiting|
|Sao Paulo, Brazil, 04005-000|
|Contact: Otavio Berwanger, PhD +55 11 30536611 ext 8203 email@example.com|
|Principal Investigator: Otavio Berwanger, PhD|
|Study Director:||Otavio Berwanger, PhD||Instituto de Ensino e Pesquisa - IEP - HCor|