Open-label, Randomised, 2-Arm Parallel Group, Multicentre, 8-week, Phase IV Study to Assess the Antihypertensive Efficacy and Safety of the Candesartan Cilexetil 16 mg and Hydrochlorothiazide 12.5 mg Combination Therapy in Comparison With Candesartan 16 mg Monotherapy in Hypertensive Adults
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Changes in Mean Sitting DBP From Baseline After 4 Weeks of Therapy
研究概览
简要总结
To compare the changes in mean sitting DBP from baseline after 4 weeks of therapy with either candesartan cilexetil/HCT combination therapy or candesartan cilexetil monotherapy regimen
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage II essential hypertension (SBP≥ 160 or DBP≥100 mmHg), untreated, or treated with a maximum of 2 class of antihypertensive drugs
排除标准
- •Current serum-creatinine >3 mg/dL, Current serum-potassium >5.5 mmol/L,
- •Pregnant or lactating women or women of childbearing potential who were not protected from pregnancy
研究组 & 干预措施
1
Candesartan cilexetil 16mg monotherapy
干预措施: Candesartan Cilexetil (Drug)
2
Candesartan cilexetil 16mg/HCT combination therapy
干预措施: Candesartan Cilexetil (Drug)
2
Candesartan cilexetil 16mg/HCT combination therapy
干预措施: Hydrochlorothiazide (Drug)
3
candesartan cilexetil 32mg monotherapy
干预措施: Candesartan Cilexetil (Drug)
4
Candesartan Cilexetil 32 mg/HCT combination therapy
干预措施: Hydrochlorothiazide (Drug)
4
Candesartan Cilexetil 32 mg/HCT combination therapy
干预措施: Candesartan Cilexetil (Drug)
结局指标
主要结局
Changes in Mean Sitting DBP From Baseline After 4 Weeks of Therapy
时间窗: 4 weeks
Mean of the changed DBP from baseline after 4 weeks
次要结局
- Changes in Mean Sitting SBP From Baseline After 4 Weeks of Therapy(4 weeks)
- Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 4 Weeks of Therapy(4 weeks)
- Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 8 Weeks of Therapy(8 weeks)
- Changes in Mean Sitting SBP From Baseline After 8 Weeks of Therapy(8 weeks)
- Changes in Hs-CRP Level From Baseline After 8 Weeks of Therapy(8 weeks)
- Occurrence of Adverse Events (AE) and Discontinuation of Study Medication Due to AE's From Baseline (Randomisation) to the End of the Study (8 Weeks)(8 weeks)
- Compliance Levels at 4 Weeks and 8 Weeks of Therapy(8 weeks)