CTRI/2010/091/000148未知3 期
An Open-labeled, Randomized, Parallel group, Active controlled, Multicentric Phase III Clinical trial to compare the efficacy, tolerability and Safety ofFixed-Dose Combination of Telmisartan and Metoprolol Succinate ERwith Telmisartan Alone in Patients of Essential Hypertension
M/s. Ravenbhel Healthcare Pvt. Ltd.4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 待定
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- To investigate whether a fixed-dose combination of 20 mg of the angiotensin receptor II antagonist telmisartan plus 25 mg of the beta-blocker Metoprolol Succinate ER is superior to 20 mg telmisartan alone in patients with mild to moderate hypertension.
研究概览
简要总结
This study is An Open-labeled, Randomized, Parallel group, Active controlled, MulticentricPhase III Clinical trial to compare the efficacy, tolerability and Safety of Fixed-Dose Combination of Telmisartan and Metoprolol Succinate ER with Telmisartan Alone in Patients of Essential Hypertension in 200 patients will be conducted in 4 centres in India
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
入选标准
- •?Male and female outpatients ³ 18 years of age.
- •?Females must be either irreversibly sterilized or post-menopausal as defined by the absence of menstruation for at least 24 months.
- •?Essential hypertensive patients who meet the following criteria.oMean supine DBP >= 95 and <= 114 mm Hg at each of Visits 2 and
- •oMean supine systolic blood pressure (SBP) must be >= 140 and <= 200 mm Hg at Visit 3.?Able to stop current antihypertensive therapy without risk to the patient.
- •?Patients who are able and are willing to comply with the protocol and have signed IEC or IRB approved Informed Consent Form.?Patients who are able to adequately maintain the diary.
排除标准
- •?Not willing to sign the ICF,?Known or suspected secondary hypertension.?Mean SBP equal to or greater than 200 mmHg?Patients with abnormal clinical chemistry, hematology, urinalysis, or ECG test results that are considered clinically significant by the investigator or the sponsor.?Patients with significant hepatic disease (liver function tests x 2 upper limit of normal reference range) or significant renal disease (creatinine x 2 upper limit of normal reference range).?Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients post-renal transplant or with only one functioning kidney ?Uncorrected volume or sodium depletion or hyponatremia?Primary aldosteronism ?Hereditary fructose intolerance ?Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists ?History of drug or alcohol dependency within the previous six months. Chronic administration of any medication known to affect blood pressure, other than the trial medication ?Concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form. ?Symptomatic congestive heart failure (New York Heart Academy (NYHA) functional class CHF II-IV).
- •unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery less than three months prior to informed consent ?Stroke less than six months prior to informed consent ?Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant arrhythmias as determined by the investigator.?Hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve ?Insulin-dependent diabetes mellitus whose diabetes has not been stable and controlled for the previous three months ?Night-shift workers who routinely sleep during the daytime and whose working hours include midnight to 4: 00 AM?Known allergic hypersensitivity to any component of the formulations under investigation ?Concomitant therapy with lithium, cholestyramine or colestipol resins. non-compliance with study medication (defined as less than 80% or more than 120%) during the run-in period ?Current treatment with any antihypertensive agent ?Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan or Metoprolol ?Patients being treated with any of the excluded medications mentioned in the protocol.?Patients with concomitant diseases such as malignancy, HIV ?Pregnancy and lactation.?Females of childbearing potential may not be recruited.
结局指标
主要结局
To investigate whether a fixed-dose combination of 20 mg of the angiotensin receptor II antagonist telmisartan plus 25 mg of the beta-blocker Metoprolol Succinate ER is superior to 20 mg telmisartan alone in patients with mild to moderate hypertension.
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
研究点 (4)
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