Efficacy and Safety of Olmesartan Medoxomil/Hydrochlorothiazide Combination 20/25 mg Versus 40/25 mg in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil 40 mg Monotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,011
- 主要终点
- Change in Mean Trough Sitting Diastolic Blood Pressure
研究概览
简要总结
The study will evaluate the blood pressure lowering effects of two different dosages of the combination of olmesartan and hydrochlorothiazide in patients with moderate or severe 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
- 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
- •Male or female Europeans aged 18 years or older with moderate to severe HTN, defined as follows (conventional BP measurements)
排除标准
- •Female patients of childbearing potential pregnant, lactating or planning to become pregnant during the trial period.
- •Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the study medication, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological or oncological, neurological and psychiatric diseases.
- •Patients having a history of the following within the last six months:
- •myocardial infarction,
- •unstable angina pectoris,
- •percutaneous coronary intervention,
- •severe heart failure,
- •hypertensive encephalopathy, cerebrovascular accident (stroke) or
- •transient ischaemic attack.
- •Patients with clinically significant abnormal laboratory values at screening.
- •Patients with secondary HTN.
研究组 & 干预措施
1
olmesartan medoximil (OM)/ hydrochlorothiazide (HCTZ) 40/25 mg + OM/HCTZ 20/25 mg matching placebo
干预措施: olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets (Drug)
2
olmesartan medoximil (OM)/ hydrochlorothiazide (HCTZ)20/25 mg + OM/HCTZ 40/25 matching placebo
干预措施: olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg (Drug)
结局指标
主要结局
Change in Mean Trough Sitting Diastolic Blood Pressure
时间窗: 8 weeks
Change in mean trough sitting diastolic Blood Pressure between OM/HCTZ 20/25 mg vs. 40/25 mg, in those patients inadequately controlled on OM 40 mg monotherapy, after eight weeks of double blind treatment, as compared to baseline. Change = Week 16 - Week 8 (baseline).
次要结局
- Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12(4 weeks)
- Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline.(8 weeks)
- Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline.(8 weeks)
- Number of Participants Achieving Blood Pressure Goal.(8 weeks)