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

NCT01404078 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 518

Last updated 2014-12-01

Study results available
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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.

Conditions

Interventions

DRUG

Single Dose Polycap

Low strength polycap contains Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin

DRUG

Double dose Polycap

2 Capsules of low strength polycap with 30mEq of Potassium

Sponsors & Collaborators

  • Population Health Research Institute

    collaborator OTHER

  • St. John's Research Institute

    lead OTHER

Principal Investigators

  • Dr.Prem - Pais, MD · St.Johns Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-02-28
Completion
2011-02-28

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01404078 on ClinicalTrials.gov