Efficacy and Safety of Hydrochlorothiazide (HCTZ) Used as Add-on Therapy in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil (OM) 40 mg Monotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 972
- 主要终点
- Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16
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 hypertension (HTN)
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
4
olmesartan medoxomil (OM) /hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
干预措施: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo (Drug)
1
olmesartan medoxomil (OM) /hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
干预措施: olmesartan medoxomil/hydrochlorothiazide tablets (Drug)
3
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
干预措施: olmesartan medoxomil/hydrochlorothiazide tablets (Drug)
2
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
干预措施: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets (Drug)
结局指标
主要结局
Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16
时间窗: 8 weeks, change = week 16 - week 8
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 = week 12 - week 8)
- Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 16.(8 weeks, change = week 16 - week 8)
- Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 12.(4 weeks, change = week 12 - week 8)
- Number of Patients Achieving Target Blood Pressure at Week 16(8 weeks)
- Change in Mean 24-hour Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.(8 weeks, change = week 16 - week 8)
- Change in Mean Daytime Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.(8 weeks, change = week 16 - week 8)
- Change in Mean Night-time Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.(8 weeks, change = week 16 - week 8)