NCT01556997已完成3 期
Perindopril Amlodipine for the Treatment of Hypertension (PATH): A Multicenter, Randomized, Double-Blind, Parallel-Group Study Evaluating the Efficacy and Safety of a Fixed-Dose Combination of Perindopril Arginine Plus Amlodipine Besylate Versus Perindopril Erbumine and Amlodipine Besylate in Subjects With Essential Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 837
- 主要终点
- Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP).
研究概览
简要总结
The purpose of the study is to evaluate the safety and efficacy of a fixed-dose combination drug compared to two other drugs (monotherapies) in controlling hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Essential hypertension
- •For female subjects, a negative serum pregnancy test
- •Ability to provide written informed consent
排除标准
- •Night shift workers whose work hours include midnight to 4:00 a.m.
- •Secondary hypertension
- •An arm size that precludes the use of the digital blood pressure monitor cuff (arm size > 42 cm)
- •Renal dysfunction, severe renal impairment, bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, subjects with only 1 kidney, or post-renal transplant subjects
- •Female subjects who are pregnant, planning to become pregnant
- •History of malignancy within 5 years
- •Primary aldosteronism
- •Heart failure (NYHA functional class 3-4), hypertrophic obstructive cardiomyopathy, or hemodynamically relevant stenosis of the aortic or mitral valve
- •Significant cardiac arrhythmias, MI, stroke, CABG, PTCA, unstable angina
- •Known hypersensitivity to any component of the study drugs
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Amlodipine Besylate (AMLb)
Active Comparator
干预措施: Amlodipine Besylate (Drug)
XOMA 985
Experimental
fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)
干预措施: XOMA 985 (Drug)
Perindopril Erbumine (PERe)
Active Comparator
干预措施: Perindopril Erbumine (Drug)
结局指标
主要结局
Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP).
时间窗: Day 0 to Day 42
次要结局
- Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP).(Day 0 to Day 42)
研究者
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