CTRI/2019/07/020126Not Applicable3 期
A Multicentric, Randomized, Double Blind, Parallel Group, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Azelnidipine Tablets 8 mg / 16 mg versus Amlodipine Tablets 5 mg / 10 mg in subjects with essential hypertension
试验速览
- 阶段
- 3 期
- 状态
- Not Applicable
- 入组人数
- 236
- 试验地点
- 6
- 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, Parallel Group, Comparative, Phase III Clinical Study to Evaluatethe Efficacy, Safety and Tolerability of Azelnidipine Tablets 8 mg / 16 mgversus Amlodipine Tablets 5 mg / 10 mg in subjects with essential hypertension.
Primary objective: To evaluate the efficacy of Azelnidipine Tablets 8 mg / 16mg in subjects with essential hypertension.
Secondary objective: To evaluate the safety and tolerability of Azelnidipine Tablets 8 mg /16 mg in subjects with essential 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 1 essential hypertension having mean seated systolic BP (SeSBP) 140 to 159 mmHg and mean seated diastolic BP (SeDBP) 90 to 99 mmHg.
- •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 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)
- 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)
研究者
研究点 (6)
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