A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY OF PF-00489791 IN SUBJECTS WITH STAGE 1 AND 2 ESSENTIAL HYPERTENSION USING AMBULATORY BLOOD PRESSURE MONITORING (ABPM)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 135
- 试验地点
- 20
- 主要终点
- Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) as Measured by Ambulatory Blood Pressure Monitoring (ABPM) at Day 28
研究概览
简要总结
The purpose of this study is to evaluate the safety and blood pressure lowering effect of different doses of PF-00489791 in patients with mild to moderate high blood pressure
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and/or Females of non-childbearing potential between 18 and 70 years of age
- •History of mild to moderate hypertension
排除标准
- •Type 1 or 2 diabetes on prescribed medications
- •Secondary, severe, or malignant hypertension
- •History of a significant cardiovascular event within the last 12 months of enrollment
研究组 & 干预措施
Placebo
干预措施: placebo (Drug)
PF-00489791 20 mg titrated to 40 mg
干预措施: PF-00489791 (Drug)
PF-00489791 4 mg
干预措施: PF-00489791 (Drug)
PF-00489791 10 mg
干预措施: PF-00489791 (Drug)
结局指标
主要结局
Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) as Measured by Ambulatory Blood Pressure Monitoring (ABPM) at Day 28
时间窗: From 08:00 to 16:00 hours on Baseline (Day 0, 1 day prior to first double-blind dose of study drug) and Day 28
The ABPM device was automatically programmed to inflate at every 20 minutes from 05:00 until 21:59 hours and from 22:00 to 04:59 hours the device inflated every 60 minutes. 24-hour clock time was used. ABPM was performed in this study on Baseline, Day 1, 14 and 28. Mean daytime SBP was an average of SBP measurements taken between 08:00 and 16:00 hours by ABPM device on the specified time points. In this outcome measure change from baseline in mean daytime SBP at Day 28 is reported.
次要结局
- Change From Baseline in Cuff SBP and DBP at Day 28(Baseline (pre dose value on Day 1 of treatment), Day 28)
- Change From Baseline in Mean Daytime Diastolic Blood Pressure (DBP) as Measured by ABPM at Day 28(From 08:00 to 16:00 hours on Baseline (Day 0, 1 day prior to first double-blind dose of study drug) and Day 28)
- Minimum and Maximum SBP and DBP as Measured by ABPM Over 24 Hours on Baseline, Day 1, 14 and 28(Over 24 hours on Baseline (Day 0, 1 day prior to first double-blind dose of study drug), Day 1, 14 and 28)
- Number of Participants With Clinically Significant Laboratory Abnormalities(Day 1 up to 14 days after last dose of study drug (maximum up to 42 days))
- Change From Baseline in Heart Rate at Baseline, Day 1, 7, 14, 21, 28 and 31(Baseline (pre dose value on Day 1 of treatment), Day 1, 7, 14, 21, 28, 31)
- Change From Baseline in Mean 24-Hour SBP and DBP as Measured by ABPM at Day 28(Over 24 hours on Baseline (Day 0, 1 day prior to first double-blind dose of study drug) and Day 28)
- Change From Baseline in Cuff Mean Arterial Pressure (MAP) at Day 28(Baseline (pre dose value on Day 1 of treatment), Day 28)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(Day 1 up to 14 days after last dose of study drug (maximum up to 42 days))
- Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings(Day 1 up to 14 days after last dose of study drug (maximum up to 42 days))
- Change From Baseline in Cuff SBP and DBP at Day 31(Baseline (pre dose value on Day 1 of treatment), Day 31)