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- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: SD Polycap without potassium
Single dose polycap without pottasium
|
Low strength polycap contains Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin
Otros nombres:
|
|
Experimental: DD Polycap plus potassium
Double Dose polycap with potassium
|
2 Capsules of low strength polycap with 30mEq of Potassium
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
BLOOD PRESSURE LIPIDS
Periodo de tiempo: 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
Periodo de tiempo: 8 weeks
|
8 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Blood Pressure Reduction and Lipid Lowering in Type 2 Diabetics
Periodo de tiempo: 8 weeks
|
8 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Dr.Prem - Pais, MD, St.Johns Research Institute
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedades cardiovasculares
- Trastornos del metabolismo de la glucosa
- Enfermedades metabólicas
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Arteriosclerosis
- Enfermedades arteriales oclusivas
- Enfermedades del sistema endocrino
- Diabetes mellitus
- Aterosclerosis
- Enfermedad coronaria
- Carrera
- Enfermedades cardíacas
- Enfermedad de la arteria coronaria
- Isquemia miocardica
- Diabetes Mellitus, Tipo 2
- Enfermedades Vasculares
- Accidente cerebrovascular isquémico
- Isquemia
- Enfermedad arterial periférica
- Enfermedades vasculares periféricas
Otros números de identificación del estudio
- TIPS K
- CTRI/2010/091/000054 (Identificador de registro: Clinical Trials Registry of India)
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