- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01404078
Study to Compare 2 Doses of Polycap Versus Single Dose of Polycap With or Without Pottasium (TIPSK)
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
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
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
- Coronary artery disease; previous myocardial infarction (>7 days post uncomplicated MI), or
- Ischemic heart disease with significant ECG changes or a positive stress test, or
- Stable angina or unstable angina and with documented evidence of multi-vessel (angiography or ECG or CT angiography) coronary artery disease, or
- PTCA or CABG Surgery >30 days before informed consent.
- Cerebrovascular disease; Previous Ischemic stroke or Transient Ischemic Attacks >30 days before informed consent.
- High risk diabetes mellitus defined as HbA1C >7.5%, with microalbuminuria or blood pressure >140/90 mm Hg.
- 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.
- Those who provide informed consent and can comply with medications and follow-up visits.
Exclusion Criteria:
- 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.
- History of bleeding or having hemorrhagic stroke anytime in the past or a need for continued anticoagulation therapy.
- Patients having indication for higher doses of aspirin or needing more than 75mg of clopidogrel daily.
- Have significant bradycardia (heart rate <50 beats/min) or second- or third-degree heart block without a pacemaker.
- Planned cardiac surgery or PTCA or any non-cardiac surgery <3months of eligibility assessment.
- Heart transplant recipient.
- Renal dysfunction defined as serum creatinine >2 mg/dL and/or serum potassium >5.0 mEq/L.
- 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.
- Hepatic dysfunction, SGOT or SGPT > 3 x ULN.
- Taking another experimental drug or within 30days of last dose of the experimental drug.
- Peptic ulcer disease with bleed, or bleeding diathesis.
- Bronchial asthma or Chronic Obstructive Pulmonary Disease with asthma.
- Gout, rheumatoid arthritis or other chronic inflammatory disease requiring long-term medications with NSAIDs.
- Any history of muscular pain, other pathology of the muscles or past history of muscular pain secondary to taking statins or fibrates.
- Pregnancy or lactating or women of childbearing potential with inadequate contraception.
- Inability to attend follow up visits (due to significant disability, inadequate address or contact details, subject from a far off place, psychiatric illness etc.).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: SD Polycap without potassium
Single dose polycap without pottasium
|
Low strength polycap contains Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin
Andere namen:
|
|
Experimenteel: DD Polycap plus potassium
Double Dose polycap with potassium
|
2 Capsules of low strength polycap with 30mEq of Potassium
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
BLOOD PRESSURE LIPIDS
Tijdsspanne: 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.
|
8 weeks
|
|
Tolerability of a Double Dose of Half Strength Polycap
Tijdsspanne: 8 weeks
|
8 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Blood Pressure Reduction and Lipid Lowering in Type 2 Diabetics
Tijdsspanne: 8 weeks
|
8 weeks
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Dr.Prem - Pais, MD, St.Johns Research Institute
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Hart-en vaatziekten
- Glucosemetabolismestoornissen
- Metabole ziekten
- Cerebrovasculaire aandoeningen
- Hersenziekten
- Ziekten van het centrale zenuwstelsel
- Ziekten van het zenuwstelsel
- Arteriosclerose
- Arteriële occlusieve ziekten
- Endocriene systeemziekten
- Suikerziekte
- Atherosclerose
- Hart-en vaatziekte
- Hartinfarct
- Hartziekten
- Coronaire hartziekte
- Myocardiale ischemie
- Diabetes mellitus, type 2
- Vaatziekten
- Ischemische beroerte
- Ischemie
- Perifere arteriële ziekte
- Perifere vaataandoeningen
Andere studie-ID-nummers
- TIPS K
- CTRI/2010/091/000054 (Register-ID: Clinical Trials Registry of India)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .