Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
Intervention1: Fixed-Dose Combination of Bisoprolol Fumarate 5 mg, Telmisartan 40 mg and
Chlorthalidone 12.5 mg tablets.: Oral Tablets for 84 Days
Control Intervention1: Fixed-Dose Combination of Meto
Sponsors
Windlas Biotech Limited
Windlas Biotech Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Willing to give consent to participate 2. Female or male aged 18-65 (both inclusive) years at the time of consent. 3. Patients must have uncontrolled essential hypertension with stable coronary artery disease (CAD) having mean seated SBP less than 140 to 179 and DBP of less than 90 to 109 mmHg despite being on a stable regimen of dual anti-hypertensive for at least 4 weeks prior to study entry. 4. Must demonstrate a mean seated SBP less than 140-179 and DBP less than 90-109 mmHg; [Note: Mean seated BP is defined as the average of 3 seated BP measurements at any single clinical site visit]. 5. Have no change in background therapy regimen and dose consisting of a stable regimen of dual anti-hypertensive agents including a beta-blocker such as Bisoprolol Fumarate 5 mg (or equivalent dose of any other beta blocker) for at least 4 weeks prior to study entry (participants who do not meet this criterion may be rescreened at the Investigator s discretion). 6. In case of females, non-child bearing potential (surgically sterile or menopausal) OR females of child bearing potential using effective birth control measures and nonpregnant & non-lactating females having a negative serum/urine pregnancy test.
Exclusion criteria
Exclusion criteria: Patient will be excluded if any exclusion criteria listed below are met: 1. Has a mean seated SBP more than 180 mmHg or DBP more than 110 mmHg at Screening; [Note: Mean seated BP is defined as the average of 3 seated BP measurements at any single clinical site visit.] 2. Body mass index less than 40 kg^m2 at Screening; 3. Patients previously sensitive to any of the ingredients of the investigational products. 4. Patients with a known history of secondary or malignant hypertension. 5. Patients with EF less than 40 percent on 2D Echo. 6. New York Heart Association (NYHA) class IV Congestive Heart Failure. 7. MI, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment. 8. Coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) or valvular repair/replacement within 12 weeks prior to enrolment or is planned to undergo any of these procedures after randomization. 9. Any condition outside the renal and CV disease area, such as but not limited to malignancy, with a life expectancy of less than 2 years based on investigator s clinical judgement. 10. Active malignancy requiring treatment at the time of visit 1. 11. Hepatic impairment (aspartate transaminase [AST] or alanine transaminase [ALT]less than 3x the upper limit of normal [ULN]; or total bilirubin less than 2x ULN at time of enrolment). 12. Abnormal Serum Potassium (K+ equal to 3.5 to 5.1 mmol^L). 13. Abnormal TSH value at screening. 14. Renal Impairment (eGFR less than 60 mL^min per 1.73m2). 15. Type 1 Diabetes Mellitus or uncontrolled Type 2 DM (HbA1c more than 9.5 percent). 16. Patients otherwise judged to be inappropriate for inclusion in the study by the investigator s judgment. 17. Patients with known alcohol or drug abuse history. 18. Patients with known History of HIV, Hepatitis B and C. 19. Known history of blood-borne diseases. 20. Women of child-bearing potential (i.e., those who are not chemically or surgically sterilized or who are not post-menopausal) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator OR women who have a positive pregnancy test at enrolment or randomization OR women who are breast-feeding. 21. Participation in another clinical study with an IP during the last month prior to enrolment. 22. Inability of the patient, in the opinion of the investigator, to understand and/or comply with IP, procedures and/or follow-up OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean seated systolic blood pressure SeSBPTimepoint: Baseline to week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in mean seated systolic Blood Pressure SeSBPTimepoint: Baseline to Week 4 and 8;Change in mean seated diastolic Blood Pressure SeDBPTimepoint: Baseline to week 4,8 and 12;Percentage of the patients achieved the target levels of clinical SeSBPTimepoint: Week 4,8 and 12;Percentage of the patients achieved the target levels of clinical SeDBPTimepoint: Week 4,8 and 12;Proportion of responders of dosing (Responder rate defined as the proportion of patients with decrease in diastolic BP at least 10 mmHg)Timepoint: After 12 weeks | — |
Countries
India
Contacts
Public ContactMr Kartik Sahni
Insignia Clinical Services
Outcome results
None listed