PER-060-01已完成未知
A MULTICENTER DOUBLE BLIND, RANDOMIZED, PARALLEL GROUP STUDY TO EVALUATE THE EFFECTS OF TWO DIFFERENT DOSIS OF LOSARTAN ON MORBIDITY AND MORTALITY IN PATIENTS WITH SYMPTOMATIC HEART FAILURE INTOLERANT TO ACE INHIBITOR TREATMENT
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2001年9月11日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
- 年龄范围
- 0 至 0（—）
入选标准
- •Be at least 18 years old.
- •Have symptomatic heart failure (NYHA Functional Class II, m or IV) with known or newly diagnosed intolerance to treatment with ACE inhibitors and who is currently receiving or not an Angiotensin II Antagonist (AAII). The intolerance to the lECA according to the clinical criteria of the investigator is defined as the therapy with a lECA discontinued by an event related to an ACEI that includes: cough, symptomatic hypotension, azotemia, hyperkalemia, dysgeusia, rash or gastrointestinal disorder In patients with intolerance to the ACE inhibitors recently diagnosed, these symptoms must have decreased after 2 weeks of discontinuation of treatment with an ACE inhibitor.
- •Have a left ventricular ejection fraction <40% as measured by a validated method (eg, radionuclide ventriculography, contrast angiography, MRI, or echocardiography within 3 months prior to randomization). If the patient has had an intercurrent event, the measurement of the ejection fraction should be confirmed before randomization.
- •Have received unchanged doses of concomitant cardiovascular therapy (including diuretics, digitalis, vasodilators, alpha and beta adrenergic receptor antagonists, and calcium channel blockers, AAUs, etc.) for at least 14 days before the transition period of open tag.
排除标准
- •Have a history of known intolerance to the angiotensin II receptor antagonist.
- •(If you are a woman) Being pregnant or breastfeeding. (All patients who become pregnant during the study should discontinue the study therapy and inform the Clinical Monitor immediately).
- •Have a systolic blood pressure in the supine, sitting or standing position <90 mm Hg at the time of randomization.
- •Have hemodynamically significant stenotic valvular heart disease.
- •Have myocarditis or active pericarditis.
- •Have a heart transplant planned for this patient for the next 6 months.
- •Have coronary angioplasty (CA) within 12 weeks, or coronary bypass graft surgery (CIBC) within 12 weeks prior to randomization.
- •Have an acute myocardial infarction or unstable angina within 12 weeks prior to randomization.
- •Have a stroke or transient ischemic attack within 12 weeks prior to randomization.
- •Have documented or suspected significant renal artery stenosis and any medical condition in which the administration of a vasodilator is contraindicated.
- •Have other factors that may affect your participation (for example, a significant concurrent or life-limiting illness such as cancer, a mental or legal disability, alcohol or drug abuse within the past 2 years, a projected extended trip in the next 3 years, a test with the research drug within the last 4 weeks).
- •Have clinically important abnormal laboratory results in the last baseline local laboratory examination that include:
- •or serum creatinine> 2.5 mg / dL (> 220 fimol / L),
- •or serum potassium <3.5 or> 5.7 mEq / L (<3.5 or> 5.7 mmol / L)
- •or TGOS / TGPS (ALT / AST) 3 times higher than the normal upper limit
- •or blood hemoglobin (males and females <10 g / dL (6.206 mmol / L)
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