CTRI/2019/12/022455已完成3 期
A Multicentric, Randomized, Double Blind, Parallel Group, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of FDC of Benidipine 4 mg plus Telmisartan 40 mg Tablets and FDC of Benidipine 4 mg plus Telmisartan 80 mg Tablets versus Telmisartan Tablets 40 mg and Telmisartan Tablets 80 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
- 240
- 试验地点
- 19
- 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 Evaluate the Efficacy, Safety and Tolerability of FDC of Benidipine 4 mg plus Telmisartan 40 mg Tablets and FDC of Benidipine 4 mg plus Telmisartan 80 mg Tablets versus Telmisartan Tablets 40 mg and Telmisartan Tablets 80 mg monotherapy in subjects with stage 2 hypertension.
Primary objective:
To evaluate the efficacy of FDC of Benidipine 4 mg plus Telmisartan 40 mg Tablets and FDC of Benidipine 4 mg plus Telmisartan 80 mg Tablets in subjects with stage 2 hypertension.
Secondary objective:
To evaluate the safety and tolerability of FDC of Benidipine 4 mg plus Telmisartan 40 mg Tablets and FDC of Benidipine 4 mg plus Telmisartan 80 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
- 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 more than 20 mg of Hg for systolic blood pressure and morethan 10 mm of Hg for diastolic blood pressure after assuming the standing posture from supine or sitting position).
- •Subjects with known case of symptomatic congestive heart failure, unstable angina pectoris, sinus node dysfunction and any clinically significant cardiac arrhythmias.
- •Subject who has had myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery in last 1 year.
- •Subjects with known case of Stroke.
- •Subjects with abnormal Renal Function Test (RFT).
- •Subjects with abnormal eGFR (less than 60 mL per min per 1.73 m2).
- •Subjects with known case of bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant or with only one functioning kidney.
- •Subjects with hyponatremia as per blood biochemistry results at screening.
- •Subjects with hyperkalemia and hypokalemia as per blood biochemistry results at screening.
- •Subjects with abnormal Liver Function Tests (Total bilirubin, SGOT & SGPT) with values more than 2.5 times the upper limit of normal.
- •Subjects with abnormal Thyroid Function Test (TSH)
- •Subjects with known case of Type 1 Diabetes.
- •Subjects with Type 2 Diabetes Mellitus whose diabetes has not been stable and controlled for the previous three months and with HbA1c value greater than 8%.
- •Subjects with medical history of Oncological Conditions since last 2 years.
- •Subjects with clinical history of bipolar disorder i.e. who are taking lithium.
- •Subjects with known case of HIV, Hepatitis B & C.
- •Female subjects who are pregnant or lactating or planning to become pregnant during the study period.
- •Females who are not ready to use acceptable contraceptive methods during the course of study.
- •Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
- •Currently taking prohibited concomitant medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
- •Suspected inability or unwillingness to comply with the study procedures.
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 1, 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 1, 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)
- The assessment of safety of subjects [comparison of incidence of treatment emergent adverse event (TEAE)].(At Week 1, Week 2, Week 4, Week 8 and Week 12)
- The assessment of tolerability of investigational product will be based on incidence of AEs and SAEs and changes in laboratory values.(At Week 1, Week 2, Week 4, Week 8 and Week 12)
研究者
研究点 (19)
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