Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
Intervention1: Metoprolol Succinate ER 25 mg plus Chlorthalidone 12.5 mg plus Telmisartan 40 mg Tablets: Subject have to take given medication once daily for 24 weeks at around same time.
Intervention
Sponsors
Ajanta Pharma Ltd
Eligibility
Inclusion criteria
Inclusion criteria: To be eligible for the study, Subjects must meet the following criteria: 1. Male or female subjects aged between 18 and 65 years (both inclusive). 2. Subjects of stable coronary artery disease (no change in severity of symptoms or nitrate consumption in previous 3 months). 3. Subjects with the history of uncontrolled essential hypertension [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 fixed drug combination therapy of Metoprolol Succinate ER (25 mg / 50 mg) plus Telmisartan 40 mg Tablets for at least 4 weeks. 4. As judged by the Investigator, based on a medical evaluation performed during the screening period. The medical evaluation must include normal or non-clinically significant physical examination, laboratory examination and 12-lead ECG. 5. Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures. 6. 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.
Exclusion criteria
Exclusion criteria: Subjects with any of the following conditions will be excluded from the study: 1. Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation. 2. Subjects diagnosed with Secondary or Malignant Hypertension. 3. Surgical or medical condition that, in the judgment of the Investigator or Sponsor, could interfere with absorption, distribution, metabolism, or excretion of the drugs to be used. 4. Renal system: 4.1 Subjects with abnormal Renal Function Test ( Serum Creatinine Normal range, 0.6 to 1.3 mg/dL) and (BUN Normal range , 7 to 20 mg/dL) 4.2 Subjects with abnormal eGFR (less than 60 mL/min/1.73 m2). 4.3 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. 4.4 Subjects with hyponatremia as per blood biochemistry results at screening (Normal range, 135 to 145 mEq/L). 4.5 Subjects with hyperkalemia and hypokalemia as per blood biochemistry results at screening (Normal range, 3.5 to 5.5 mEq/L). 5. Hepatic system: 5.1 Subjects with abnormal Liver Function Test with values more than 2.5 times the upper limit of normal. 6. Endocrine system: 6.1 Subjects with abnormal Thyroid Function Test (TSH) (Normal range is 0.45 to 4.5 mIU/mL). 6.2 Subjects with Type 1 Diabetes Mellitus. 6.3 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%. 7. Cardiovascular system: 7.1 Subjects with known case of symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery, sinus node dysfunction and any clinically significant cardiac arrhythmias. 7.2 Subjects with known case of Stroke. 8. Other disease conditions 8.1 Subject with clinical history of Bronchospastic disorders. 8.2 Subjects with medical history of Oncological Conditions since last 2 years. 8.3 Subjects with known case of Epileptic seizures. 8.4 Subjects with clinical history of bipolar disorder i.e. who are taking lithium. 9. Trial related conditions 9.1 Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent. 9.2 Currently taking prohibited concomitant medications(s) listed and inability/unwillingness to discontinue them for the entire study period. 9.3 Suspected inability or unwillingness to comply with the study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy and safety of Metoprolol Succinate ER 25 mg plus Chlorthalidone 12.5 mg plus Telmisartan 40 mg Tablets and Metoprolol Succinate ER 50 mg plus Chlorthalidone 12.5 mg plus Telmisartan 40 mg Tablets in Subjects with uncontrolled essential Hypertension and stable coronary artery disease (CAD). Timepoint: Mean change in SeDBP between baseline and 24 weeks Mean change in SeSBP between baseline and 24 weeks. The assessment of safety of subjects [comparison of incidence of treatment emergent adverse event (TEAE)]. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the tolerability of Metoprolol Succinate ER 25 mg plus Chlorthalidone 12.5 mg plus Telmisartan 40 mg Tablets and Metoprolol Succinate ER 50 mg plus Chlorthalidone 12.5 mg plus Telmisartan 40 mg Tablets in Subjects with uncontrolled essential Hypertension and stable coronary artery disease (CAD). Timepoint: Mean change in SeDBP from baseline [Time frame: 12, 16, 20 weeks] Mean change in SeSBP from baseline [Time frame: 12, 16, 20 weeks] Proportion of patients achieving SeDBP less than 90 mmHg (SeDBP responder) [Time frame: 12, 16, 20, 24 weeks] Proportion of patients achieving SeSBP less than 140 mmHg (SeSBP responder) [Time frame: 12, 16, 20, 24 weeks] Mean change in Ambulatory Blood Pressure (Mean 24 hour SBP and DBP) from baseline to the end of study (24 weeks). | — |
Countries
India
Contacts
Public ContactDr Shailesh Singh
Ajanta Pharma Ltd
Outcome results
None listed