CTRI/2021/11/037926已完成3 期
A Randomized, Double Blind, Parallel Group, Multicentric, 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 Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 264
- 试验地点
- 10
- 主要终点
- •Mean change in Seated Systolic Blood Pressure (SeSBP) from baseline to Week-12
研究概览
简要总结
This is a Randomized, Double Blind, Parallel Group,Multicentric, Phase-III clinical study to compare the Efficacy, Safety andTolerability of FDC of Telmisartan 40mg + Bisoprolol 5 mg tablets versus FDC ofTelmisartan 40mg + Metoprolol Succinate ER 50 mg tablets in the treatment ofStage 1 and Stage 2 Hypertension
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
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.Patients aged 18-65 years of age of both gender 2.Subject with essential hypertension with seated systolic BP (SeSBP) ≥140 to ≤180 mmHg and having seated diastolic BP (SeDBP) ≥ 90 to ≤ 110 mmHg (Stage 1 and Stage 2 Hypertension, Indian Hypertension Guidelines –IV, 2019).
- •3.Subjects on monotherapy with either ARB (Telmisartan, Olmesartan, Azilsartan, Losartan) or CCBs (Amlodipine, Benidipine, Cilnidipine, Efonidipine, Azilnidipine) or Bisoprolol or Metoprolol since ≥12 weeks 4.Female subjects of childbearing potential using adequate contraception 5.Willingness to sign written informed consent document.
排除标准
- •1.Women of childbearing potential if pregnant (test positive for pregnancy) at screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study 2.Presence of any clinically relevant disease/disorder (e.g. severe hepatic impairment, chronic renal failure, thromboembolic disorders, recent acute myocardial infarction, history of bronchial asthma, severe COPD etc.) 3.Surgical or medical condition that, in the judgment of the Investigator could interfere with absorption, distribution, metabolism, or excretion of the drugs to be used.
- •4.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 5.Subjects who has evidence of a secondary hypertension.
- •6.Any known cardiac disease/disorder in which any of the study medication is contra-indicated (e.g. severe bradycardia, heart block greater than first degree or significant first degree block, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome without pacemaker etc.) 7.Refusal or inability to comply with the requirements of the protocol for any reason, including scheduled clinic visits and laboratory tests.
- •8.Any significant illness or drugs that could interfere with study parameters 9.Subject with known allergy or hypersensitivity to any of the components of the formulation 10.Any other condition that in opinion of the investigator does not justify patient’s participation in study.
- •11.Participation in another clinical trial within past 30 days.
结局指标
主要结局
•Mean change in Seated Systolic Blood Pressure (SeSBP) from baseline to Week-12
时间窗: •Mean change in Seated Systolic Blood Pressure (SeSBP) from baseline to Week-12 | •Mean change in Seated Diastolic Blood Pressure (SeDBP) from baseline to Week-12
•Mean change in Seated Diastolic Blood Pressure (SeDBP) from baseline to Week-12
时间窗: •Mean change in Seated Systolic Blood Pressure (SeSBP) from baseline to Week-12 | •Mean change in Seated Diastolic Blood Pressure (SeDBP) from baseline to Week-12
次要结局
- Proportion of subjects achieving Seated Systolic Blood Pressure (SeSBP) less than 140 mmHg from baseline to Week-12(Proportion of subjects achieving Seated Diastolic Blood Pressure (SeDBP) less than 90 mmHg from baseline to Week-12)
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
尚未招募
3 期
A Study to Evaluate the Efficacy and Safety of HLX15-IV Versus DARZALEX® in Combination with Lenalidomide-Dexamethasone (Rd) in Transplant-ineligible Patients with Newly Diagnosed Multiple MyelomaNCT06895512Shanghai Henlius Biotech386
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
Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus)Refractory Reflux EsophagitisNCT01669811AstraZeneca1,398