A Randomized, Double-blind, Double-dummy, Placebo-controlled, 4x4 Factorial Design Trial to Evaluate Telmisartan 20, 40 and 80 mg Tablets in Combination With Amlodipine 2.5, 5 and 10 mg Capsules After Eight Weeks of Treatment in Patients With Stage I or II Hypertension, With an ABPM Sub-study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,461
- 试验地点
- 136
- 主要终点
- Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)
研究概览
简要总结
To demonstrate that Micardis and Norvasc when used together are more effective at lowering blood pre ssure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double
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
- •Exclusion criteria:
排除标准
- •Patient is pregnant; breast-feeding; unwilling to use birth control during the study; has secondary hypertension; severe renal dysfunction; hepatic insufficiency; stroke within the last six 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 for the past three months defined as a glucosylates hemoglobin (HbA1c) greater than ten percent ; history of angioedema or hypersensitivity related to either study drug.
- •Systolic Blood Pressure (SBP) is greater than or equal to 180 millimeters of mercury (mmHg), Diastolic Blood Pressure (DBP) is greater than or equal to 110 mmHg.
研究组 & 干预措施
Placebo
Placebo once daily for eight weeks
干预措施: Placebo (Drug)
Telmisartan 20 mg
Telmisartan 20 mg once daily for eight weeks
干预措施: Telmisartan 20 mg (Drug)
Telmisartan 40 mg
Telmisartan 40 mg once daily for eight weeks
干预措施: Telmisartan 40 mg (Drug)
Telmisartan 80 mg
Telmisartan 80 mg once daily for eight weeks
干预措施: Telmisartan 80 mg (Drug)
Amlodipine 2.5 mg
Amlodipine 2.5 mg once daily for eight weeks
干预措施: Amlodipine 2.5 mg (Drug)
Amlodipine 5 mg
Amlodipine 5 mg once daily for eight weeks
干预措施: Amlodipine 5 mg (Drug)
Amlodipine 10 mg
Amlodipine 5 mg for two weeks and forced titrated to amlodipine 10 mg for six weeks once daily
干预措施: Amlodipine 5 mg (Drug)
Amlodipine 10 mg
Amlodipine 5 mg for two weeks and forced titrated to amlodipine 10 mg for six weeks once daily
干预措施: Amlodipine 10 mg (Drug)
Telmisartan 20 / Amlodipine 2.5
Telmisartan 20/ Amlodipine 2.5 mg once daily for eight weeks
干预措施: Telmisartan 20 mg (Drug)
Telmisartan 20 / Amlodipine 2.5
Telmisartan 20/ Amlodipine 2.5 mg once daily for eight weeks
干预措施: Amlodipine 2.5 mg (Drug)
Telmisartan 20 / Amlodipine 5
Telmisartan 20 / Amlodipine 5 mg once daily for eight weeks
干预措施: Telmisartan 20 mg (Drug)
Telmisartan 20 / Amlodipine 5
Telmisartan 20 / Amlodipine 5 mg once daily for eight weeks
干预措施: Amlodipine 5 mg (Drug)
Telmisartan 20 / Amlodipine 10
Telmisartan 20 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks
干预措施: Amlodipine 10 mg (Drug)
Telmisartan 20 / Amlodipine 10
Telmisartan 20 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks
干预措施: Telmisartan 20 mg (Drug)
Telmisartan 20 / Amlodipine 10
Telmisartan 20 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks
干预措施: Amlodipine 5 mg (Drug)
Telmisartan 40 / Amlodipine 2.5
Telmisartan 40 / Amlodipine 2.5 for eight weeks
干预措施: Amlodipine 2.5 mg (Drug)
Telmisartan 40 / Amlodipine 2.5
Telmisartan 40 / Amlodipine 2.5 for eight weeks
干预措施: Telmisartan 40 mg (Drug)
Telmisartan 40 / Amlodipine 5
Telmisartan 40 / Amlodipine 5 for eight weeks
干预措施: Amlodipine 5 mg (Drug)
Telmisartan 40 / Amlodipine 5
Telmisartan 40 / Amlodipine 5 for eight weeks
干预措施: Telmisartan 40 mg (Drug)
Telmisartan 40 / Amlodipine 10
Telmisartan 40 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks
干预措施: Telmisartan 40 mg (Drug)
Telmisartan 40 / Amlodipine 10
Telmisartan 40 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks
干预措施: Amlodipine 10 mg (Drug)
Telmisartan 40 / Amlodipine 10
Telmisartan 40 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks
干预措施: Amlodipine 5 mg (Drug)
Telmisartan 80 / Amlodipine 2.5
Telmisartan 80 / Amlodipine 2.5 for eight weeks
干预措施: Amlodipine 2.5 mg (Drug)
Telmisartan 80 / Amlodipine 2.5
Telmisartan 80 / Amlodipine 2.5 for eight weeks
干预措施: Telmisartan 80 mg (Drug)
Telmisartan 80 / Amlodipine 5
Telmisartan 80 / Amlodipine 5 mg for eight weeks
干预措施: Telmisartan 80 mg (Drug)
Telmisartan 80 / Amlodipine 5
Telmisartan 80 / Amlodipine 5 mg for eight weeks
干预措施: Amlodipine 5 mg (Drug)
Telmisartan 80 / Amlodipine 10
Telmisartan 40 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks
干预措施: Amlodipine 5 mg (Drug)
Telmisartan 80 / Amlodipine 10
Telmisartan 40 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks
干预措施: Telmisartan 80 mg (Drug)
Telmisartan 80 / Amlodipine 10
Telmisartan 40 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks
干预措施: Amlodipine 10 mg (Drug)
结局指标
主要结局
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)
时间窗: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)
时间窗: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
Observed results
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects)
时间窗: End-of-study visit (LOCF)
Observed results
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)
时间窗: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)
时间窗: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) (Observed Telmisartan Effect)
时间窗: Baseline to end-of-study (up to 8 weeks) visit (Last Observation Carried Forward (LOCF))
Observed results
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)
时间窗: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.
Change From Baseline in Seated Trough Cuff Mean DBP (Observed Telmisartan Effect)
时间窗: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
Observed results
Change From Baseline in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)
时间窗: Up to 8 weeks (LOCF)
Observed results
Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)
时间窗: Up to 8 weeks (LOCF)
Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.
Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)
时间窗: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.
Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects)
时间窗: Up to 8 weeks (LOCF)
Observed results
Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)
时间窗: Up to 8 weeks (LOCF)
Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.
Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)
时间窗: Up to 8 weeks (LOCF)
Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.
次要结局
- DBP Response(Up to 8 weeks (LOCF))
- Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP(Up to 8 weeks (LOCF))
- Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP)(Baseline to end-of-study (up to 8 weeks) visit (LOCF))
- Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP(Baseline to end-of-study (up to 8 weeks) visit (LOCF))
- Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP(Baseline to end-of-study (up to 8 weeks) visit (LOCF))
- DBP Control(Up to 8 weeks (LOCF))
- SBP Response(Up to 8 weeks (LOCF))
- BP Normality(Up to 8 weeks (LOCF))
- Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP(End-of-study (up to 8 weeks) visit (LOCF))
- Change From Baseline in ABPM 24-hour Mean SBP(Up to 8 weeks (LOCF))
- Change From Baseline in ABPM 24-hour Mean DBP(Up to 8 weeks (LOCF))
- Change From Baseline in Seated Trough Pulse Rate(Up to 8 weeks (LOCF))
- Orthostatic Change in Trough Cuff Mean DBP(Week 8)
- Orthostatic Change in Trough Cuff Mean SBP(Week 8)
- Change From Baseline in Seated Trough Cuff Mean SBP(Up to 8 weeks (LOCF))
- Change From Baseline in Standing Trough Cuff Mean DBP(Up to 8 weeks (LOCF))
- Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG)(8 weeks)
- Change From Baseline in Standing Trough Cuff Mean SBP(Up to 8 weeks (LOCF))