NCT00550953已完成3 期
Filtered Trial for Telmisartan 40mg Non-responder
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 314
- 试验地点
- 5
- 主要终点
- Decrease in Seated Diastolic Blood Pressure From Baseline to 8 Weeks
研究概览
简要总结
The primary purpose of this study is to:
Demonstrate that a fixed-dose combination of telmisartan 40 mg plus amlodipine 5 mg is superior to telmisartan 40 mg alone in patients with essential hypertension and inadequately controlled with telmisartan 40 mg monotherapy.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Essential hypertensive patients who satisfying non-responder criteria
- •Male or Female
- •Age 20 years or older
排除标准
- •Taking four or more anti-hypertensive medications
- •Secondary hypertension
- •Mean seated diastolic blood pressure (DBP) > 114 mmHg and/or mean seated systolic blood pressure (SBP) > 200 mmHg at Visit 1, 2, 3, or 4, or mean seated DBP < 90 mmHg at Visit
- •Sustained ventricular tachycardia or other clinically relevant cardiac arrhythmias
- •Congestive heart failure patients with the New York Heart Association (NYHA) functional class III-IV
- •History of myocardial infarction or cardiac surgery within last 6 months
- •History of coronary artery bypass graft or percutaneous coronary intervention (PCI) within last 3 months
- •History of unstable angina within last 3 months
- •Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve
- •History of stroke or transient ischemic attack within last 6 months
- •History of sudden exacerbation of renal function with angiotensin II receptor blockers (ARBs) or angiotensin converting enzyme (ACE) inhibitors, or patients with post-renal transplant or post-nephrectomy
- •Experienced characteristic symptoms of angioedema during treatment with ARBs or ACE inhibitors
- •Known hypersensitivity to any component of the investigational drug , or a known hypersensitivity to dihydropyridine -derived drugs
- •Hepatic and/or renal dysfunction
- •Diagnosed biliary atresia or cholestasis
- •Hyperkalemia
- •Dehydration
- •Sodium deficiency
- •Chronic administration of high doses of acidic nonsteroidal anti-inflammatory drugs (NSAIDs)
- •Patients who cannot change to the restricted administration and dosage during study period
- •Pre-menopausal women who meet any one of the following 1 - 3:
- •Pregnant or possibly pregnant (1)
- •Nursing (2)
- •Desire to become pregnant during study period (3)
- •Drug or alcohol dependency
- •Complication of malignant tumour or a disease requiring immunosuppressants
- •Compliance of < 80% or > 120% during the run-in period
- •Receiving any investigational therapy within 3 months
- •Judged to be inappropriate by the investigator or the sub-investigator
结局指标
主要结局
Decrease in Seated Diastolic Blood Pressure From Baseline to 8 Weeks
时间窗: Baseline and 8 Weeks
The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.
次要结局
- Decrease in Seated Systolic Blood Pressure From Baseline to 8 Weeks(Baseline and 8 weeks)
- Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline)(8 weeks)
- Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline)(8 weeks)
- Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline)(8 weeks)
- Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline)(8 weeks)
- Percentage of Patients Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks (0 Percent at Baseline)(8 weeks)
- Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG(First administration of randomised treatment to 24 hours post last dose of randomised treatment)
研究者
研究点 (5)
Loading locations...
相似试验
已完成
3 期
Combination of Telmisartan 40 mg Plus Hydrochlorothiazide (HCTZ) 12.5 mg vs. Telmisartan 40 mg Alone in Patients With Essential Hypertension Who Fail to Respond Adequately to Telmisartan MonotherapyHypertensionNCT00144222Boehringer Ingelheim218
已完成
3 期
Telmisartan/Amlodipine (80/10) vs. Telmisartan/Amlodipine (40/10) vs. amlodipine10 in Resistant HypertensionHypertensionNCT00553267Boehringer Ingelheim947
已完成
3 期
Telmisartan80/HCTZ25 Versus Telmisartan80/HCTZ12.5 in Hypertension Not Responding to Telmisartan80/HCTZ12.5HypertensionNCT00239369Boehringer Ingelheim713
已完成
3 期
A Randomized, Double-blind, Parallel-group Assessment of the Safety and Efficacy of Telmisartan 40mg Plus Hydrochlorothiazide 12.5mg (Micardis Plus) in Comparison With Losartan 50mg Plus Hydrochlorothiazide 12.5mg in Taiwanese Patients With Mild to Moderate HypertensionHypertensionNCT00133185Boehringer Ingelheim31
已完成
3 期
An Eight-week Randomized,Double-blind Study to Evaluate the Efficacy and Safety of Fixed-dose Combinations of T80+A5 Versus A5 Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With A5 MonotherapyHypertensionNCT01103960Boehringer Ingelheim324