NCT01404078 (TIPSK) is a NA clinical trial of Single Dose Polycap in Ischemic Heart Disease, sponsored by St. John's Research Institute.

Who is sponsoring NCT01404078?

NCT01404078 is sponsored by St. John's Research Institute.

What drugs are being tested in NCT01404078?

Interventions in NCT01404078: Single Dose Polycap, Double dose Polycap.

What condition does NCT01404078 study?

NCT01404078 studies Ischemic Heart Disease, Ischemic Stroke, Peripheral Vascular Disease, Type 2 Diabetes Mellitus.

Is NCT01404078 still recruiting?

NCT01404078 is currently completed. Last updated 26 November 2014.

Are results published for NCT01404078?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2014-11-26 · How we verify

NCT01404078: TIPSK

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Results posted Last updated 26 November 2014

What this trial tests

NA trial testing Single Dose Polycap in Ischemic Heart Disease in 518 participants. Completed in 1 February 2011.

Timeline

1 April 2010

Primary endpoint
1 February 2011

1 February 2011

Quick facts

Lead sponsor	St. John's Research Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	518
Start date	1 April 2010
Primary completion	1 February 2011
Estimated completion	1 February 2011

Drugs / interventions tested

Single Dose Polycap — full drug profile →
Double dose Polycap — full drug profile →

Conditions studied

Ischemic Heart Disease — all drugs for Ischemic Heart Disease →
Ischemic Stroke — all drugs for Ischemic Stroke →
Peripheral Vascular Disease — all drugs for Peripheral Vascular Disease →
Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →

Sponsor

St. John's Research Institute

Who can join

40 and older, any sex, with Ischemic Heart Disease or Ischemic Stroke. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Other St. John's Research Institute trials

Trials by the same sponsor.

NCT06926946 — SafeBoosC-IIIv - Does Cerebral Oximetry Monitoring Affect Renal Outcomes · NA · not yet recruiting
NCT06836661 — Impact, Cost, and Sustainability of a Customized, Low-Cost Intervention to Reduce Cardiovascular Disease Burden in India · NA · not yet recruiting
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NCT07132840 — Combined Effects of Balance Training and Taping in People With Functional Ankle Instability. · NA · completed
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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01404078 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by St. John's Research Institute
Last refreshed: 26 November 2014

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01404078.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing