- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: SD Polycap without potassium
Single dose polycap without pottasium
|
Low strength polycap contains Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin
Autres noms:
|
|
Expérimental: DD Polycap plus potassium
Double Dose polycap with potassium
|
2 Capsules of low strength polycap with 30mEq of Potassium
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
BLOOD PRESSURE LIPIDS
Délai: 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
Délai: 8 weeks
|
8 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Blood Pressure Reduction and Lipid Lowering in Type 2 Diabetics
Délai: 8 weeks
|
8 weeks
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Dr.Prem - Pais, MD, St.Johns Research Institute
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Maladies cardiovasculaires
- Troubles du métabolisme du glucose
- Maladies métaboliques
- Troubles cérébrovasculaires
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Artériosclérose
- Maladies artérielles occlusives
- Maladies du système endocrinien
- Diabète sucré
- Athérosclérose
- Maladie coronarienne
- Accident vasculaire cérébral
- Maladies cardiaques
- Maladie de l'artère coronaire
- Ischémie myocardique
- Diabète sucré, Type 2
- Maladies vasculaires
- AVC ischémique
- Ischémie
- Maladie artérielle périphérique
- Maladies vasculaires périphériques
Autres numéros d'identification d'étude
- TIPS K
- CTRI/2010/091/000054 (Identificateur de registre: Clinical Trials Registry of India)
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