A Multi-Center, Double-Blind, Randomized, Active-Controlled, Comparative,Parallel-Group, Phase III Clinical Study to Evaluate the Efficacy and Safety of Fixed DoseCombination of Azelnidipine plus Metoprolol Succinate Tablets in the Treatment of Subjects withStage 2 Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 15
- 主要终点
- Change from baseline in mean sitting systolic blood pressure (msSBP) at the end of study visit (Week 12).
研究概览
简要总结
After informed consent process, completion of all screening assessments and once all the inclusion/exclusion criteria are met, the eligible subjects
shall be enrolled into the study. Demographics, Medical and surgical history, details of concomitant medications and adverse events if any shall be recorded during screening visit. Physical examination (including general and systemic examinations) shall be done during screening and each successive visit. Vital signs (like blood pressure, pulse rate, respiratory rate and body temperature) shall be measured on each visit.
Ambulatory blood pressure monitoring shall be performed during screening visit and end of study visit.
Urine pregnancy test for females of childbearing potential shall be performed during screening visit and end of study visit. Laboratory assessment shall be performed on screening, week 2, week 4, week 8 and week 12/ end of study visit. Urine Examination (Routine & Microscopic) shall be performed during screening visit and end of study visit. 12 Lead ECG examination shall be performed during screening and end of study visit. Abdominal Ultrasonography shall be performed during Screening visit and Echocardiography at Screening and end of visit .
At randomization/baseline visit, subjects shall be randomly (Double blind) assigned in 1:1:1:1:1:1 fashion to one of the six treatment groups. Study drug shall be dispensed by the independent dispenser or designated personnel at the investigative site who shall not participate in any other activity pertaining to subject’s safety and efficacy assessment that may impact the study outcome.
Subject shall be instructed to administer, One Tablet Once a Day orally with water in the morning after breakfast around same time every day for 12 weeks.
Patients shall complete six scheduled clinic visits as follows:
• Visit 1: Screening Visit (-7 Days)
• Visit 2: Randomization/Baseline Visit (Day 1)
• Visit 3: Interim Visit (Week 2/Day 14 ± 2 days)
• Visit 4: Interim Visit (Week 4/Day 28 ± 2 days)
• Visit 5: Interim Visit (Week 8/Day 56 ± 2 days)
• Visit 6: End of Study/Early Discontinuation Visit (Week 12/Day 84 ± 4 days)
A subject diary shall be provided to the subjects to record administration of the study medication, concomitant medication details and adverse events if any. All subjects shall be instructed to complete the subject diary after each administration. Any additional administration and missed administration should also be noted in subject diary. Subject diary shall be used to evaluate the compliance to study drug administration.
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 and non-pregnant, non-lactating female subjects between 18 to 65 years of age (both inclusive).
- •Treatment-Naïve subjects or subjects who are on stable dose of antihypertensive medications from last 4 weeks, with mean sitting systolic blood pressure (msSBP) ≥ 160 mmHg to < 180 mmHg, and mean sitting diastolic blood pressure (msDBP) ≥ 100 mmHg to < 110 mmHg (3 readings will be taken by accredited automated blood pressure machine in sitting position, first reading will be taken after 15 min.
- •rest and subsequent two readings will be taken at the interval of 2 min.
- •Female Subjects, of child bearing potential practicing an acceptable method of birth control such as sexual abstinence, intrauterine device IUD, birth control pills, a double-barrier method, transdermal, injection or implants, non-hormonal or hormonal, condom plus spermicide, diaphragm plus spermicide, or vaginal spermicidal suppository; for the duration of the study as judged by the investigator(s)/study physician and agree to follow the same should be used during treatment.
- •OR Postmenopausal for at least 1 year.
- •OR Surgically sterile (bilateral tubal ligation/bilateral oophorectomy/ hysterectomy has been performed on the Subject).
- •Note: Subjects entering the study who are on hormonal contraceptives must have been on the method for at least 90 days prior to the study and continue the method for the duration of the study.
- •Subjects who had used hormonal contraception and stopped must have stopped no less than 90 days prior to the study.
- •Subjects who are able to understand and give voluntary, written informed consent to participate in this clinical investigation and from whom written consent has been obtained.
- •Subjects shall be willing and able to understand and comply with the requirements of the study, administer the study medication as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
排除标准
- •Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation.
- •Female subjects who are pregnant or lactating or planning to become pregnant during the study period.
- •Female subjects with positive urine pregnancy test at screening.
- •Subjects with secondary or malignant hypertension
- •Subjects with myocardial infarction or cerebrovascular disorder within 3 months before informed consent.
- •7.Subjects with unstable angina pectoris, severe heart failure (NYHA class III or IV) and serious arrhythmia (grade II or III atrioventricular block).
- •Subjects with abnormal eGFR (<60 mL/min/1.73 m2) will be excluded from the study.
- •Subjects with abnormal Liver Function Test with values more than 2.5 times the upper limit of normal.
- •10.Subjects with Type 1 Diabetes or Type 2 Diabetes Mellitus with HbA1c value greater than 8% will be excluded from the study.
- •Subjects with known case of Oncological Conditions.
- •Subject with any clinically significant laboratory abnormalities at screening visit.
- •Subjects with any other medical condition that might adversely impact the safety of the study participants or confound the study results.
- •Subjects who consume excessive amounts of alcohol, abuse drugs, or have any condition that would compromise compliance with this protocol.
- •Subjects who have been treated with an investigational drug or investigational device within a period of 4 weeks prior to study entry.
- •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
Change from baseline in mean sitting systolic blood pressure (msSBP) at the end of study visit (Week 12).
时间窗: Baseline/Visit 2 (Day 1), Visit 3 (week 2), Visit 4 (well 4), Visit 5 (week 8), End of Study/Visit 6 (Week 12)
次要结局
- Change from baseline in mean sitting diastolic blood pressure (msDBP) at the end of study visit (Week 12)(Baseline/Visit 2 (Day 1), Visit 3 (week 2), Visit 4 (well 4), Visit 5 (week 8), End of Study/Visit 6 (Week 12))
- Change from baseline in Ambulatory Blood Pressure at the end of study/early(discontinuation visit (Week 12))