CTRI/2018/10/015899尚未招募3 期
A Multicentric, Randomized, Double Blind, Parallel Group, Comparative, Phase III clinical study to evaluate the Efficacy, Safety and Tolerability of Azelnidipine Tablets 16 mg Versus Amlodipine Tablets 10 mg in subjects with essential hypertension
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 228
- 试验地点
- 10
- 主要终点
- To evaluate the efficacy and safety of Azelnidipine Tablets 16 mg in subjects with essential hypertension
研究概览
简要总结
A Multicentric, Randomized, Double Blind, Parallel Group,Comparative, Phase III clinical study to evaluate the Efficacy, Safety andTolerability of Azelnidipine Tablets 16 mg Versus Amlodipine Tablets 10 mg insubjects with essential hypertension.
PrimaryObjective: To evaluate the efficacy and safety of Azelnidipine Tablets 16 mg insubjects with essential hypertension.
SecondaryObjective: To evaluate the tolerability of Azelnidipine Tablets 16 mg in subjectswith 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
- •1.Male or female subjects of age 18-65 years (both inclusive).
- •2.Treatment naïve subjects diagnosed with mean sitting SBP of ≥160 to ≤180 mm Hg and mean sitting DBP ≥100 to ≤110 mm Hg (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.
- •3.Subjects with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
- •4.Subjects willing to comply with the protocol requirements.
排除标准
- •1.Subjects with known hypersensitivity to any of the components of the formulation.
- •2.Any surgical or medical condition which might alter the absorption, distribution, metabolism or excretion of study drug.
- •3.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.
- •4.Cardiovascular system: •Known case of secondary or malignant hypertension.
- •â€¢Known case of symptomatic congestive heart failure, severe aortic stenosis, unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery and any clinically significant cardiac arrhythmias.
结局指标
主要结局
To evaluate the efficacy and safety of Azelnidipine Tablets 16 mg in subjects with essential hypertension
时间窗: Change from baseline in mean sitting SBP to the end of study (12 weeks)
次要结局
- To evaluate the tolerability of Azelnidipine Tablets 16 mg in subjects with essential hypertension(Change from baseline in mean sitting DBP at the end of study (12 weeks).)
研究者
研究点 (10)
Loading locations...
相似试验
尚未招募
3 期
A Study of Combination of Efonidipine Hydrochloride Ethanolate 20 mg/20 mg and Metoprolol Succinate ER 25 mg/ 50 mg Tablets Versus Efonidipine Hydrochloride Ethanolate Tablets 20 mg and Metoprolol Succinate ER Tablets 50 mg Monotherapy for the treatment of Hypertension.CTRI/2018/12/016625Ajanta Pharma Ltd300
Unknown
3 期
A Study of Azelnidipine Tablets for the treatment of subjects with HypertensionCTRI/2019/07/020126Synokem Pharmaceuticals Ltd236
已完成
3 期
A Study of Combination of Azilsartan Medoxomil plus Cilnidipine Tablets for the treatment of subjects with Hypertension.CTRI/2019/07/020204Synokem Pharmaceuticals Ltd222
已完成
3 期
A Study of Combination of Benidipine plus Telmisartan Tablets for the treatment of subjects with Hypertension.CTRI/2019/12/022455Synokem Pharmaceuticals Ltd240
已完成
3 期
A Phase-III clinical study to compare the Efficacy, Safety and Tolerability of FDC of Telmisartan 40mg plus Bisoprolol 5 mg tablets versus FDC of Telmisartan 40mg plus Metoprolol Succinate ER 50 mg tablets in the treatment of Stage 1 and Stage 2 HypertensionCTRI/2021/11/037926Micro Labs Limited264