Study to Compare 2 Doses of Polycap Versus Single Dose of Polycap With or Without Pottasium

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus; Ischemic Heart Disease; Peripheral Vascular Disease; Ischemic Stroke
• Interventions: Drug: Single Dose Polycap; Drug: Double dose Polycap

• Registration Number: NCT01404078
• Lead Sponsor: St. John's Research Institute

Brief Summary

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.

Detailed Description

Mean change in blood pressure between those taking 2capsules of the polycap versus one Difference in Rates of early discontinuation between 2 capsules of polycap versus one Rates of reported adverse effects among those taking the polycap

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Study First Submitted: 2011-07-24
• Study First Submitted QC: 2011-07-26
• Study First Posted: 2011-07-27
• Results First Submitted: 2014-05-19
• Status Verified: 2014-11
• Results First Submitted QC: 2014-11-26
• Last Update Submitted: 2014-11-26
• Results First Posted: 2014-12-01
• Last Update Posted: 2014-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 518

Inclusion Criteria

1. Individuals 40 years and above, with a seated blood pressure > 130/80 mm Hg on two consecutive readings (or BP > 120/80 mm Hg in patients under treatment with 2 or more antihypertensive medication) with one of the following

   1. Coronary artery disease; previous myocardial infarction (>7 days post uncomplicated MI), or
   2. Ischemic heart disease with significant ECG changes or a positive stress test, or
   3. Stable angina or unstable angina and with documented evidence of multi-vessel (angiography or ECG or CT angiography) coronary artery disease, or
   4. PTCA or CABG Surgery >30 days before informed consent.
   5. Cerebrovascular disease; Previous Ischemic stroke or Transient Ischemic Attacks >30 days before informed consent.
   6. High risk diabetes mellitus defined as HbA1C >7.5%, with microalbuminuria or blood pressure >140/90 mm Hg.
   7. Peripheral artery disease defined as a current or prior history of: physician diagnosed intermittent claudication or vascular surgery for atherosclerotic disease or an ankle/arm systolic blood pressure ratio ≤ 0.90 in either leg at rest, or angiographic or doppler study demonstrating ≥ 70% stenosis in a noncardiac artery.

2. Those who provide informed consent and can comply with medications and follow-up visits.

Exclusion Criteria

1. Known hypersensitivity or intolerance to any of the study medications or a clear indication for full doses of beta blockers, RAAS blockers (ACEi, ARBs, Renin inhibitors, etc.), diuretics and statins.
2. History of bleeding or having hemorrhagic stroke anytime in the past or a need for continued anticoagulation therapy.
3. Patients having indication for higher doses of aspirin or needing more than 75mg of clopidogrel daily.
4. Have significant bradycardia (heart rate <50 beats/min) or second- or third-degree heart block without a pacemaker.
5. Planned cardiac surgery or PTCA or any non-cardiac surgery <3months of eligibility assessment.
6. Heart transplant recipient.
7. Renal dysfunction defined as serum creatinine >2 mg/dL and/or serum potassium >5.0 mEq/L.
8. Patients aged >70 years, with mild renal dysfunction defined as serum creatinine >124 µmol/L (1.4 mg/dL) or eGFR <45 ml/min/1.73 m2.
9. Hepatic dysfunction, SGOT or SGPT > 3 x ULN.
10. Taking another experimental drug or within 30days of last dose of the experimental drug.
11. Peptic ulcer disease with bleed, or bleeding diathesis.
12. Bronchial asthma or Chronic Obstructive Pulmonary Disease with asthma.
13. Gout, rheumatoid arthritis or other chronic inflammatory disease requiring long-term medications with NSAIDs.
14. Any history of muscular pain, other pathology of the muscles or past history of muscular pain secondary to taking statins or fibrates.
15. Pregnancy or lactating or women of childbearing potential with inadequate contraception.
16. Inability to attend follow up visits (due to significant disability, inadequate address or contact details, subject from a far off place, psychiatric illness etc.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SD Polycap without potassium	Single Dose Polycap	Single dose polycap without pottasium
DD Polycap plus potassium	Double dose Polycap	Double Dose polycap with potassium

Primary Outcome Measures

Name	Time	Method
Tolerability of a Double Dose of Half Strength Polycap	8 weeks
BLOOD PRESSURE LIPIDS	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.

Secondary Outcome Measures

Name	Time	Method
Blood Pressure Reduction and Lipid Lowering in Type 2 Diabetics	8 weeks