A Multicentric, Randomized, Double Blind, Parallel Group, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of FDC of Azilsartan Medoxomil 40 mg plus Cilnidipine 5 mg Tablets and FDC of Azilsartan Medoxomil 40 mg plus Cilnidipine 10 mg Tablets versus Azilsartan Medoxomil Tablets 40 mg and Cilnidipine Tablets 10 mg monotherapy in subjects with stage 2 hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 222
- 试验地点
- 24
- 主要终点
- Mean change in seated systolic blood pressure (SeSBP) between baseline and 12 weeks. [For subjects who are discontinued due to lack of efficacy last SBP reading at the time of discontinuation will be considered as end point]
研究概览
简要总结
A Multicentric, Randomized, Double Blind, ParallelGroup, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safetyand Tolerability of FDC of Azilsartan Medoxomil 40 mg + Cilnidipine 5 mgTablets and FDC of Azilsartan Medoxomil 40 mg + Cilnidipine 10 mg Tabletsversus Azilsartan Medoxomil Tablets 40 mg and Cilnidipine Tablets 10 mg monotherapyin subjects with stage 2 hypertension.
Primary objective: To evaluate theefficacy and safety of FDC of AzilsartanMedoxomil 40 mg + Cilnidipine 5 mg Tablets and FDC of Azilsartan Medoxomil 40 mg + Cilnidipine 10 mg Tabletsin subjects with stage 2 hypertension.
Secondary objective: To evaluate thetolerability of FDC of AzilsartanMedoxomil 40 mg + Cilnidipine 5 mg Tablets and FDC of Azilsartan Medoxomil 40 mg + Cilnidipine 10 mg Tabletsin subjects with stage 2 hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female subjects aged between 18 and 65 years (both inclusive).
- •Treatment naïve subjects diagnosed with stage 2 hypertension having mean seated SBP of ≥160 to ≤180 mmHg and mean seated DBP ≥100 to ≤110 mmHg (3 readings will be taken by validated automated blood pressure machine in sitting position, first reading will be taken after 15 min.
- •rest and subsequent two readings will be recorded at the interval of 2 min.
- •Subjects with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
- •Subjects willing to comply with the protocol requirements.
排除标准
- •Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation.
- •Any surgical or medical condition which might alter the absorption, distribution, metabolism or excretion of the study drug.
- •Has clinical laboratory evaluations (including biochemistry and hematology) are not within the reference range for the testing laboratory and the results are deemed clinically significant by the investigator.
- •Subjects with known case of secondary or malignant hypertension.
- •Subjects with evidence of postural hypotension (defined as drop in >20 mmHg for systolic blood pressure and >10 mmHg for diastolic blood pressure after assuming the standing posture from supine or sitting position).
结局指标
主要结局
Mean change in seated systolic blood pressure (SeSBP) between baseline and 12 weeks. [For subjects who are discontinued due to lack of efficacy last SBP reading at the time of discontinuation will be considered as end point]
时间窗: At Baseline, Week 2, Week 4, Week 8 and Week 12
次要结局
- Mean change in ambulatory blood pressure (Mean 24 hour SBP and DBP) from baseline to the end of study (12 weeks)(At baseline and Week 12)
- Mean change in seated diastolic blood pressure (SeDBP) between baseline and 12 weeks. [For subjects who are discontinued due to lack of efficacy last DBP reading at the time of discontinuation will be considered as end point](At Baseline, Week 2, Week 4, Week 8 and Week 12)