A Multicentric Randomized Double Blind Double Dummy Parallel Group Comparative Phase III Clinical Study to Evaluate the Efficacy Safety and Tolerability in subjects with Uncontrolled Essential Hypertension with stable Coronary Artery Disease (CAD).
- Conditions
- Health Condition 1: I10- Essential (primary) hypertension
- Registration Number
- CTRI/2022/11/047055
- Lead Sponsor
- Ajanta Pharma Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Male or female subjects aged between 18 and 75 years.
2.Subjects of stable coronary artery disease.
3.Subjects with the history of uncontrolled essential hypertension with stable coronary artery disease [having seated diastolic BP (SeDBP) 90 to 110 mmHg and seated systolic BP (SeSBP) 140 to 180 mmHg] who is on the stable dose of Metoprolol succinate ER 50 mg plus Telmisartan 40 mg Tablets for at least 4 weeks.
4.Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
5.Female subjects of childbearing potential must be willing to use acceptable method of contraception or post-menopausal for at least one year or surgically sterile.
1.Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation.
2.Subjects with EF less than 40% as per Simpsonâ??s method on 2D Echo.
3.Subjects diagnosed with Secondary or Malignant Hypertension.
4.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.
5.Renal system:
Subjects with eGFR more than 60 mL per min per 1.73m2
Subjects with abnormal lab values of Na, K, Mg and Uric acid. normal range: Na
Equal to135 to 145 mEq per L, K equal to 3.5 to 5.0 mmol per L, Mg equal to 7 to 12 mg per dL and Uric acid 3.5 to 7.2 mg per dL
6.Hepatic system:
Subjects with abnormal Liver Function Test with values more than 2.5 times the upper limit of normal.
7.Endocrine system:
Subjects with abnormal Thyroid Function Test, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus with HbA1c value greater than 8%.
8.Cardiovascular system:
Subjects with known case of symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) less than one year or coronary artery bypass graft (CABG) surgery less than one year, sinus node dysfunction and any clinically significant cardiac arrhythmias.
Subjects with known case of Stroke.
9.Other disease conditions
Subject with clinical history of COPD, Bronchial Asthma and Peripheral Vascular disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in SeSBP between baseline and 12 weeks. <br/ ><br>The assessment of safety of subjects, comparison of incidence of treatment emergent adverse event (TEAE). <br/ ><br>Timepoint: Baseline and 12 weeks
- Secondary Outcome Measures
Name Time Method Mean change in SeDBP from baseline Time frame: 4, 8 and 12 weeks. <br/ ><br>Mean change in SeSBP from baseline Time frame: 4, 8 and 12 weeks. <br/ ><br>Proportion of patients achieving SeSBP 140 mmHg (SeSBP responder) Time frame: 4, 8 and 12 weeks. <br/ ><br>Proportion of patients achieving SeDBP less than 90 mmHg (SeDBP responder) Time frame 4, 8 and 12 weeks. <br/ ><br>Mean change in Ambulatory Blood Pressure (Mean 24 hour SBP and DBP) from baseline to the end of study (12 weeks). <br/ ><br>The assessment of safety and tolerability of Investigational Product will be based on incidence of AEs and SAEs and changes in laboratory values <br/ ><br>Timepoint: 4, 8 and 12 weeks