The Indian Polycap Study 2 (TIPSK)

This study has been completed.
Sponsor:
Collaborator:
Population Health Research Institute
Information provided by (Responsible Party):
St. John's Research Institute
ClinicalTrials.gov Identifier:
NCT01404078
First received: July 24, 2011
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

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 Intervention
Ischemic Heart Disease
Ischemic Stroke
Peripheral Vascular Disease
Type 2 Diabetes Mellitus
Drug: Indian Polycap

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by St. John's Research Institute:

Primary Outcome Measures:
  • Blood pressure reduction and lowering of low density lipoprotein [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Blood pressure reduction and lipid lowering in Type 2 diabetics [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 518
Study Start Date: April 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: two doses of low strength polycap
Patients in this arm will receive 2 doses of low strength Polycap.
Drug: Indian Polycap
Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin
Other Names:
  • Polycap
  • Polypill
Active Comparator: one dose of low srength polycap
Patients in this arm will receive one dose of low strength Polycap
Drug: Indian Polycap
Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin
Other Names:
  • Polycap
  • Polypill

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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01404078

Sponsors and Collaborators
St. John's Research Institute
Population Health Research Institute
Investigators
Principal Investigator: Dr.Prem - Pais, MD St.Johns Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: St. John's Research Institute
ClinicalTrials.gov Identifier: NCT01404078     History of Changes
Other Study ID Numbers: TIPS K, CTRI/2010/091/000054
Study First Received: July 24, 2011
Last Updated: May 28, 2013
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Diseases
Ischemia
Stroke
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Atherosclerosis

ClinicalTrials.gov processed this record on July 20, 2014