A multicentric randomized double blind parallel group two arm comparative phase III clinical study to evaluate the efficacy safety and tolerability of FDC of Azelnidipine 16 mg plus Telmisartan 40 mg Film Coated Tablets Versus FDC of Amlodipine 5 mg plus Telmisartan 40 mg tablets in subjects with stage 2 hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- 1. Change from baseline in mean sitting SBP to the end of study (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, Two Arm, Comparative, Phase-III Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of FDC of Azelnidipine 16 mg plus Telmisartan 40 mg Film Coated Tablets Versus FDC of Amlodipine 5mg + Telmisartan 40 mg tablets in Subjects with 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
- •Male or Female subjects of age 18 to 65 years (both inclusive).
- •Treatment-Naïve subjects diagnosed with Stage 2 Hypertension having mean SBP of ≥160 to ≤180 mmHg and mean 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 the ability to understand and provide a written informed consent form, which must have been obtained before the screening.
- •Subjects willing to comply with the protocol requirements.
排除标准
- •1.Suspected hypersensitivity to either the study medications or any of the formulation ingredients.
- •2.Subjects with a medical history of oncological conditions for the last 2 years.
- •3.Subjects with known cases of Epileptic seizures, clinical history of bipolar disorder i.e. who are taking lithium.
- •Patients suspected to be addicted to alcohol or drug abuse or with severe complications that would make the condition more complicated were assessed by the investigator.
- •5.Subject having any disease/ abnormalities as follow, Cardiovascular system: •Subject with unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery, and any clinically significant cardiac arrhythmias.
- •â€¢Subjects with known cases of Secondary or Malignant Hypertension.
- •â€¢Subjects with known cases of symptomatic congestive heart failure, severe aortic stenosis.
- •Endocrine system: •Subjects with abnormal Thyroid Function Test (TSH) [Normal range is 0.45 to 4.5 mIU/mL].
- •â€¢Subjects with Type 1 Diabetes Mellitus.
- •â€¢Subjects with Type 2 Diabetes Mellitus whose diabetes has not been stable and controlled for the previous three months and with an HbA1c value greater than 8%.
- •Renal system: •Subjects with hyperkalemia and hypokalemia as per blood biochemistry results at screening [Normal range 3.5 to 5.5 mEq/L.
- •â€¢Subjects with hyponatraemia as per blood biochemistry results at screening [Normal range 135 to 145 mEq/L].
- •â€¢Subjects with abnormal Renal Function Test (RFT) [Serum Creatinine Normal range 0.6 to 1.3 mg/dL] & [BUN Normal range 7 to 20 mg/dL].
- •â€¢Subjects with abnormal eGFR (<60 mL/min/1.73 m2).
- •â€¢Subjects with known cases of bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant, or with only one functioning kidney.
- •Hepatic system: •Subjects with abnormal Liver Function Tests with values more than 2.5 times the upper limit of normal.
- •6.Female subjects who are pregnant or lactating or planning to become pregnant during the study period.
- •8.Concurrent participation in another clinical trial or any investigational therapy within 30 days before signing informed consent.
- •9.Currently taking prohibited concomitant medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
- •10.Suspected inability or unwillingness to comply with the study procedures.
结局指标
主要结局
1. Change from baseline in mean sitting SBP to the end of study (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: 1. Change from baseline in mean sitting SBP to the end of study (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]. | 2. The assessment of safety of Subjects (comparison of incidence of treatment emergent adverse event (TEAE)).
2. The assessment of safety of Subjects (comparison of incidence of treatment emergent adverse event (TEAE)).
时间窗: 1. Change from baseline in mean sitting SBP to the end of study (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]. | 2. The assessment of safety of Subjects (comparison of incidence of treatment emergent adverse event (TEAE)).
次要结局
- 1. Change from baseline in mean sitting DBP at the end of study (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].(2. Mean change in Ambulatory Blood Pressure (12 weeks) (Approximately for 25% of study population).)