A Double Blind, Randomized, Parallel Study to Assess the Effects of Aliskiren/Amlodipine and Amlodipine Monotherapy on Ankle Foot Volume (AFV) in Patients naïve to Trial Drugs With Mild to Moderate Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Change in the Ankle Foot Volume (AFV) as Measured by Displacement Method
研究概览
简要总结
The purpose of the present study was to evaluate the addition of aliskiren, to amlodipine can attenuate ankle edema formation in hypertensive patients.
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
- •Patients (male or female) with hypertension aged between 18-75 yrs.
- •Patients not treated with amlodipine or no amlodipine in previous 1 year.
- •Post-menopausal females
排除标准
- •Patients unable to switch from prior hypertensive medication.
- •Severe hypertension.
- •Pregnant or nursing females.
- •Patients with Type 1 or Type 2 diabetes mellitus
- •History of immunodeficiency diseases, including a positive Human immunodeficiency virus (HIV) (Enzyme-linked immunosorbent assay [ELISA] and Western blot) test result.
- •A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- •Other protocol-defined inclusion/exclusion criteria are applied
研究组 & 干预措施
Aliskiren/amlodipine + Placebo to amlodipine
During the first week of active treatment, patients were instructed to take one tablet of aliskiren/amlodipine 150/5 mg and one capsule of placebo to amlodipine daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 2 tablets of aliskiren/amlodipine 150/5 mg/day and 1 capsule of placebo to amlodipine.
The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day.
干预措施: Aliskiren/amlodipine (Drug)
Aliskiren/amlodipine + Placebo to amlodipine
During the first week of active treatment, patients were instructed to take one tablet of aliskiren/amlodipine 150/5 mg and one capsule of placebo to amlodipine daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 2 tablets of aliskiren/amlodipine 150/5 mg/day and 1 capsule of placebo to amlodipine.
The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day.
干预措施: Placebo to Amlodipine (Drug)
Amlodipine + Placebo to aliskiren/amlodipine
During the first week of active treatment, patients were instructed to take one capsule of amlodipine 5 mg and one tablet of placebo to aliskiren/amlodipine 150/5 mg daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 1 capsule of amlodipine 10 mg/day and 2 tablets of placebo to aliskiren/amlodipine 150/5 mg/day.
The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day.
干预措施: Amlodipine (Drug)
Amlodipine + Placebo to aliskiren/amlodipine
During the first week of active treatment, patients were instructed to take one capsule of amlodipine 5 mg and one tablet of placebo to aliskiren/amlodipine 150/5 mg daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 1 capsule of amlodipine 10 mg/day and 2 tablets of placebo to aliskiren/amlodipine 150/5 mg/day.
The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day.
干预措施: Placebo to Aliskiren/amlodipine (Drug)
结局指标
主要结局
Change in the Ankle Foot Volume (AFV) as Measured by Displacement Method
时间窗: Baseline, 4 weeks
AFV (mL) was measured using the principle of water displacement using a commercially available foot volumeter. The amount of water displaced in milliliters (mL) equals the volume of the foot/ankle. The study was terminated due to the publication of the results of a near identical study by Fogari et al. Hence, for the current study, no analysis was performed.
次要结局
未报告次要终点