NCT00281593已完成3 期
A Randomized, Double-blind, Double-dummy, Placebo-controlled, 3x4 Factorial Design Trial to Evaluate Telmisartan 20 and 80 mg Tablets in Combination With Ramipril 1.25, 10, and 20 mg Capsules After Eight Weeks of Treatment in Patients With Stage I or II Hypertension, With an ABPM Sub-study
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,354
- 试验地点
- 134
- 主要终点
- Change from baseline in seated trough Diastolic Blood pressure after 8 weeks of treatment
研究概览
简要总结
To identify dose combinations of telmisartan and ramipril that are more effective in reducing diastolic blood pressure than each of the respective monotherapies in patients with Stage I or II hypertension.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients >=18 years of age with Stage I or II hypertension defined as:
- •a mean seated cuff diastolic blood pressure >=95 and <=119 mmHg Main
排除标准
- •breast-feeding
- •unwilling to use birth control during the study
- •secondary hypertension
- •SBP>=180 mmHg
- •DBP>=120 mmHg
- •severe renal dysfunction
- •hepatic insufficiency
- •stroke within the last 6 months
- •myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past three months
- •unstable or uncontrolled diabetes
- •history of angioedema of either of the study drugs, and hypersensitivity to the study drugs.
结局指标
主要结局
Change from baseline in seated trough Diastolic Blood pressure after 8 weeks of treatment
次要结局
- Change from baseline in systolic blood pressure after 8 weeks of treatment Percentage of patients responding to treatment Changes from baseline in diastolic and systolic blood pressure hourly means over the 24 hour dosing interval as measured by ABPM
研究者
研究点 (134)
Loading locations...
相似试验
已完成
3 期
Telmisartan Fixed Dose Combination vs Amlodipine in Hypertensive Patients With Type 2 Diabetes MellitusHypertensionNCT00877929Boehringer Ingelheim706
已完成
4 期
Study to Evaluate Efficacy of Micardis® (Telmisartan) and Valsartan in Patients With Mild-to-moderate Hypertension After Missing One Dose Using Ambulatory Blood Pressure MonitoringHypertensionNCT02242318Boehringer Ingelheim440
已完成
2 期
CKD-828 Primary Hypertension Trial(Dose-selection)HypertensionNCT01128322Chong Kun Dang Pharmaceutical430
已完成
4 期
Trial to Compare the Effects of Either Telmisartan (40-80 mg PO Once Daily) or Ramipril (5-10 mg PO Once Daily) on Renal Endothelial Dysfunction in Hypertensive Patients With Type 2 DiabetesDiabetes Mellitus, Type 2HypertensionNCT00240422Boehringer Ingelheim96
已完成
4 期
INNOVATION Study - Telmisartan (Micardis) in Incipient Diabetic NephropathyDiabetic NephropathiesNCT00153088Boehringer Ingelheim527