A Randomized, Single-Blinded, Placebo-Controlled Two-Way Crossover Study To Investigate The Hemodynamic Effects Of Single Dose Vardenafil In Subjects Receiving Maraviroc
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Standing and Supine Systolic and Diastolic Blood Pressure (BP)
研究概览
简要总结
The objective of this study was to estimate the effects of a single dose of vardenafil on the blood pressure (BP) in subjects receiving maraviroc (MVC) (dosed to steady-state) and to assess the safety and tolerability of MVC in subjects receiving a single dose of vardenafil.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects. no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead electrocardiogram and clinical laboratory tests.
- •Body mass index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs).
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- •Subjects with a supine systolic BP of greater than 140 mm Hg, or a supine diastolic BP of greater than 90 mm Hg, either at Screening or at the predose measurements.
研究组 & 干预措施
1.
Maraviroc + Vardenafil
干预措施: Maraviroc (Drug)
1.
Maraviroc + Vardenafil
干预措施: Vardenafil (Drug)
2.
Maraviroc + Placebo
干预措施: Maraviroc (Drug)
2.
Maraviroc + Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
时间窗: 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose
Supine BP was taken after subjects rested for 5 minutes supine. Subjects then sat for 2 minutes and stood for 2 minutes then standing BP taken. Duplicate supine and standing BP measurements were taken per the protocol. The average of the duplicate measurements was calculated prior to data analysis.
次要结局
- Standing and Supine Pulse Rate(1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose)
- Postural Changes in Systolic and Diastolic Blood Pressure(Baseline, 6 and 12 hours post dose on Day 1 from the First Day of each Treatment Leg)
- Postural Changes in Pulse Rate(Baseline, 6 and 12 hours post dose on Day 1 from the First Day of each Treatment Leg)
- Number of Subjects With Postural Hypotension(Period 1 and Period 2 (up to 8 days))