NCT00558064已完成3 期
Filtered Trial for Amlodipine 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
- 531
- 试验地点
- 41
- 主要终点
- Reduction From Reference Baseline in Mean Seated Diastolic Blood Pressure at Trough (24-hour Post-dosing)
研究概览
简要总结
To demonstrate that a fixed-dose combination of telmisartan 40 mg plus amlodipine 5 mg is superior to amlodipine 5 mg alone in patients with essential hypertension and inadequately controlled with amlodipine 5 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 satisfying all of the following criteria;
- •Male or Female
- •Age > 20 years
- •Patients who are able to stop current anti-hypertensive therapy at Visit 1 if taking any anti-hypertensive medications
- •Patients with an ability to provide written informed consent in accordance with the related laws and guidelines such as Good Clinical Practice (GCP) and the Pharmaceutical Affairs Law.
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
Reduction From Reference Baseline in Mean Seated Diastolic Blood Pressure at Trough (24-hour Post-dosing)
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
- Clinically Relevant Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG(First administration of randomised treatment to 24 hours post last dose of randomised treatment)
- 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 With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline)(8 weeks)
- Reduction From Reference Baseline in Mean Seated Systolic Blood Pressure at Trough (24-hour Post-dosing)(Baseline and 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 Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks(8 weeks)
研究者
研究点 (41)
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
1 期
Bioequivalence Study of Telmisartan/Amlodipine Fixed Dose Combination Compared With Its Monocomponents in Healthy Male and Female VolunteersHealthyNCT02259829Boehringer Ingelheim84
已完成
2 期
CKD-828 Primary Hypertension Trial(Dose-selection)HypertensionNCT01128322Chong Kun Dang Pharmaceutical430
Unknown
4 期
Telmisartan, Amlodipine and Flow Mediated DilationHypertensionNCT01180205Johannes Gutenberg University Mainz576
已完成
3 期
Filtered Trial for Telmisartan 40mg Non-responderHypertensionNCT00550953Boehringer Ingelheim314