A Phase 2 Multi-Centre, Randomised, Double-Blind, Placebo Controlled, Dose Ranging Study Of TBC3711 In Subjects With Resistant Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Maximum Blood Pressure (BP) Increase
研究概览
简要总结
The study was to determine the safe and effective dose of TBC3711 in patients with uncontrolled high blood pressure while already taking blood pressure medications.
详细描述
The study was stopped due to Pfizer (sponsor) decision that the compound would not be involved in any further clinical development for the indication of resistant hypertension on 05 August 2008. This decision was not based on any safety or efficacy concern.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of resistant hypertension.
- •A stable anti-hypertensive drug regimen for at least 30 days.
排除标准
- •Sustained blood pressure greater than or equal to 180/120 mmHg.
- •Required use of thigh cuff for blood pressure readings.
- •Uncontrolled diabetes mellitus.
研究组 & 干预措施
placebo
干预措施: Placebo (Drug)
ARM 1
干预措施: TBC3711 (Drug)
ARM 2
干预措施: TBC3711 (Drug)
ARM 3
干预措施: TBC3711 (Drug)
ARM 4
干预措施: TBC3711 (Drug)
结局指标
主要结局
Maximum Blood Pressure (BP) Increase
时间窗: Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12
BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles). Maximum increase was calculated by subtracting baseline value from each post-dose measurement and selecting maximum of these values.
Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change
时间窗: Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12
AUEC was calculated as the positive area under the change from baseline curve for sitting and standing SBP and DBP to Week 12, estimated by the linear trapezoidal rule corrected for the pre-dose baseline value. In the event that post-dose values returned below baseline at or before Week 12, then AUEC was calculated by setting the negative values to zero and taking only the positive area into account.
次要结局
- Sitting Systolic Blood Pressure (SBP)(Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10)
- Standing Systolic Blood Pressure (SBP)(Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10)
- Sitting Diastolic Blood Pressure (DBP)(Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10)
- Standing Diastolic Blood Pressure (DBP)(Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10)
- Change From Standing to Sitting Systolic Blood Pressure (SBP) at Week 10(Pre-Dose and 2 hours Post-Dose on Week 10)
- Change From Standing to Sitting Diastolic Blood Pressure (DBP) at Week 10(Pre-Dose and 2 hours Post-Dose on Week 10)
- Change From Pre-Dose to Post-Dose in Systolic Blood Pressure (SBP) at Week 10(Pre-Dose and 2 hours Post-Dose on Week 10)
- Change From Pre-Dose to Post-Dose in Diastolic Blood Pressure (DBP) at Week 10(Pre-Dose and 2 hours Post-Dose on Week 10)