CTRI/2010/091/000054已完成3 期
A randomized double-blind 2x 2 factorial controlled trial of the efficacy and safety of low strength PolycapTM versus two doses of low strength PolycapTM and of low strength potassium supplementation in patients with stable cardio-vascular disease or ischemic heart disease.
Cadila Pharmaceuticals India Ltd. Cadila Corporate Campus', Sarkhej - Dholka Road, Bhat, Ahmedabad- 3822100 个研究点目标入组 500 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Inclusion Criteria
- •1.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
- •a.Coronary artery disease; previous myocardial infarction (>7 days post uncomplicated MI), or
- •b.Ischemic heart disease with significant ECG changes or a positive stress test, or
- •c.Stable angina or unstable angina and with documented evidence of multi-vessel (angiography or ECG or CT angiography) coronary artery disease, or
- •d.PTCA or CABG Surgery >30 days before informed consent.
- •e.Cerebrovascular disease; Previous Ischemic stroke or Transient Ischemic Attacks >30 days before informed consent.
- •f.High risk diabetes mellitus defined as HbA1C >7.5%, with microalbuminuria or blood pressure >140/90 mm Hg.
- •g.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.
- •2.Those who provide informed consent and can comply with medications and follow-up visits.
排除标准
- •Exclusion criteria
- •a.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.
- •b.History of bleeding or having hemorrhagic stroke anytime in the past or a need for continued anticoagulation therapy.
- •c.Patients having indication for higher doses of aspirin (>200 mg) or needing more than 75mg of clopidogrel daily.
- •d.Have significant bradycardia (heart rate <50 beats/min) or second- or third-degree heart block without a pacemaker.
- •e.Planned cardiac surgery or PTCA or any non-cardiac surgery <3months of eligibility assessment.
- •f.Heart transplant recipient.
- •g.Renal dysfunction defined as serum creatinine >2 mg/dL and/or serum potassium >5.0 mEq/L.
- •h.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.
- •i.Hepatic dysfunction, SGOT or SGPT > 3 x ULN.
- •j.Taking another experimental drug or within 30days of last dose of the experimental drug.
- •k.Peptic ulcer disease with bleed, or bleeding diathesis.
- •l.Bronchial asthma or Chronic Obstructive Pulmonary Disease with asthma.
- •m.Gout, rheumatoid arthritis or other chronic inflammatory disease requiring long-term medications with NSAIDs.
- •n.Any history of muscular pain, other pathology of the muscles or past history of muscular pain secondary to taking statins or fibrates.
- •o.Pregnancy or lactating or women of childbearing potential with inadequate contraception.
- •p.Inability to attend follow up visits (due to significant disability, inadequate address or contact details, subject from a far off place, psychiatric illness etc.).
研究者
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