Health Condition 1: I158- Other secondary hypertension
Conditions
Interventions
Intervention1: Fixed-Dose Combination of Bisoprolol 2.5mg, Cilnidipine 10 mg and
Telmisartan 40 mg tablet: Oral tablet, Fixed-Dose Combination of Bisoprolol 2.5mg, Cilnidipine 10 mg and
Telmisartan 40
Sponsors
Ravenbhel Healthcare Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged between 18 to 75 years. 2. Systolic BP (SBP) above or equal to 140 mmHg and diastolic BP (DBP) above or equal to 90 mmHg, despite adherence to a regimen of above or equal to 3 antihypertensive medications, including a diuretic, at optimal doses. Or, SBP above or equal to 160 mmHg and DBP above or equal to 100 mmHg, despite treatment with at least 2 antihypertensive agents. 3 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: 1. Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation. 2. Subjects with EF less than 40 percent on as per Simpson s method on 2D Echo. 3. Subjects diagnosed with 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.Subjects with eGFR less than 60 mL per min per 1.73m2 Subjects with abnormal lab values of Na+, K+, Mg++, Cl- and Uric acid as per the discretion of the principal investigator. 6. 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) or a known case of hepatic cirrhosis. 7. Subjects with abnormal Thyroid Function Test (TSH). Subjects with Type 1 Diabetes Mellitus or 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 percent. 8. Subjects with known case of symptomatic congestive heart failure, unstable angina pectoris, myocardial infraction, percutaneous transluminal coronary angioplasty (PTCA) in less than one year or coronary artery bypass graft (CABG) surgery in 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 significant first-degree block, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome without pacemaker etc.) Subjects with known case of Stroke. 9.Subject with clinical history of uncontrolled COPD or 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. 10.Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent. 11. Currently taking prohibited concomitant medications(s) listed and inability or unwillingness to discontinue them for the entire study period. 12. Suspected inability or unwillingness to comply with the study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Mean change in SeSBP from baseline to end of study 2.Mean change in SeDBP from baseline to end of studyTimepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving SeSBP less than 140 mmHgTimepoint: 12 Weeks;Proportion of patients achieving SeDBP less than 90 mmHgTimepoint: 12 Weeks;Mean change in SeDBP from baselineTimepoint: 4, 8 and 12 weeks;Mean change in SeSBP from baselineTimepoint: 4, 8 and 12 weeks;Mean change in Ambulatory Blood Pressure (Mean 24 hours SBP and DBP) between baseline and end of study for 20% of patientsTimepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactMr Sandeep Yadav
Manentia Research
Outcome results
None listed