Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
Intervention1: FDC of Telmisartan 40 mg + Amlodipine 5 mg + Bisoprolol 2.5 mg Tablets: FDC of Telmisartan 40 mg plus Amlodipine 5 mg plus Bisoprolol 2.5 mg tablets,
One tablet once a day orally in th
Sponsors
Ravenbhel Healthcare Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Male or female subjects aged between 18 and 75 years. Subjects of stable coronary artery disease. 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 Amlodipine 5 mg plus Bisoprolol 5 mg Tablets for at least 4 weeks. Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures
Exclusion criteria
Exclusion criteria: Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation. Subjects with EF less than 40 percent on as per Simpsons method on 2D Echo. Subjects diagnosed with Malignant Hypertension. 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. Renal system: Subjects with eGFR less than 60 mL/min/1.73m2 Subjects with abnormal lab values of Na+, K+, Mg++, Cl- and Uric acid. Normal range: Na+ = 135-145 mEq/L, K+ = 3.5-5.0 mmol/L, Mg++ = 1.8-2.2 mg/dL, Cl-= 96-106 mEq/L and Uric acid 3.5-7.2 mg/dL. Hepatic system: Subjects with abnormal AST, ALT and alkaline phosphate with values more than 2.5 times the upper limit of normal, Bilirubin greater than 1.5 times upper limit of normal (ULN)/ Known hepatic cirrhosis). Endocrine system: Subjects with abnormal Thyroid Function Test [Normal range TSH = 0.4 to 4.0 mIU/L, T4 = 0.8 to 2.8 ng/dL, T3 = 100 to 200 nanograms per deciliter (ng/dL)]. Subjects with Type 1 Diabetes Mellitus / Diabetes Insipidus. 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%. Cardiovascular system: Subjects with known case of symptomatic congestive heart failure, unstable angina pectoris, myocardial infraction, 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 history of bradyarrhythmia and any clinically significant cardiac arrhythmias. Any known cardiac disease/disorder in which any of the study medication is contra- indicated (e.g. severe bradycardia, heart block greater than a first degree or signific ant first-degree block, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome without pacemaker etc.) Subjects with known case of Stroke. Other disease conditions: Subject with clinical history of uncontrolled COPD/Bronchial Asthma. Subject with clinical history of Peripheral Vascular disease. Subjects with medical history of neoplastic disorders with expected survival less than 1 year. Subjects with known case of Epileptic seizures. Subjects with clinical history of bipolar disorder. 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. Female subjects of childbearing potential not be willing to use an acceptable method of contraception. Pregnant woman or lactating mother.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in SeSBP from baseline to end of study. Mean change in SeDBP from baseline to end of study.Timepoint: Mean change in SeSBP from baseline to end of study (12 weeks). Mean change in SeDBP from baseline to end of study (12 weeks). | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving SeSBP. Proportion of patients achieving SeDBP. Mean change in SeDBP from baseline to 4, 8 and 12 weeks. Mean change in SeSBP from baseline to 4, 8 and 12 weeks. Mean change in Ambulatory Blood Pressure.Timepoint: Proportion of patients achieving SeSBP less than 140 mmHg (SeSBP responder) [Time frame: 12 weeks]. Proportion of patients achieving SeDBP less than 90 mmHg (SeDBP responder) [Time frame: 12 weeks]. Mean change in SeDBP from baseline to 4, 8 and 12 weeks. Mean change in SeSBP from baseline to 4, 8 and 12 weeks. Mean change in Ambulatory Blood Pressure (Mean 24 hours SBP and DBP) between baseline and end of study (12 weeks) for 20percent of patients. | — |
Countries
India
Contacts
Public ContactDr Ujwala Salvi
Nucleon Research Pvt. Ltd.
Outcome results
None listed