Study to Compare 2 Doses of Polycap Versus Single Dose of Polycap With or Without Pottasium (TIPSK)
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|ClinicalTrials.gov Identifier: NCT01404078|
Recruitment Status : Completed
First Posted : July 27, 2011
Results First Posted : December 1, 2014
Last Update Posted : December 1, 2014
This is a randomized double blind 2x2 factorial controlled trial to evaluate efficacy tolerability of low strength Polycap versus two doses of low strength Polycap in patients with stable cardiovascular disease in reducing blood pressure and LDL.
To evaluate the tolerability and safety of low dose potassium supplementation compared to placebo in patients with stable cardiovascular disease.
Approximately 500 patients are planned to be randomized.
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Heart Disease Ischemic Stroke Peripheral Vascular Disease Type 2 Diabetes Mellitus||Drug: Single Dose Polycap Drug: Double dose Polycap||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||518 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A RCT With Factorial Design to Compare Safety and Efficacy of 2 Capsules of the Indian Polycap Versus a Single Capsule Along With or Without Oral Potassium Among Patients With Stable Cardiovascular Disease|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2011|
Active Comparator: SD Polycap without potassium
Single dose polycap without pottasium
Drug: Single Dose Polycap
Low strength polycap contains Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin
Other Name: Polycap
Experimental: DD Polycap plus potassium
Double Dose polycap with potassium
Drug: Double dose Polycap
2 Capsules of low strength polycap with 30mEq of Potassium
Other Name: Full dose polycap
- BLOOD PRESSURE LIPIDS [ Time Frame: 8 weeks ]Amongst patients with cardiovascular disease or type 2 diabetes, the study aims to test the safety and efficacy of giving double dose of polycap versus a single dose of polycap for 8 weeks; efficacy to lower blood pressure and elevated lipids and safety assessed as difference with tolerance to double dose of polycap compared to a single dose.
- Tolerability of a Double Dose of Half Strength Polycap [ Time Frame: 8 weeks ]
- Blood Pressure Reduction and Lipid Lowering in Type 2 Diabetics [ Time Frame: 8 weeks ]
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): NCT01404078
|Principal Investigator:||Dr.Prem - Pais, MD||St.Johns Research Institute|