Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
Intervention1: Group 1
Fixed-Dose Combination of Bisoprolol 2.5mg, Cilnidipine 10 mg and Telmisartan 40 mg tablet: One tablet for 84 days
Intervention2: Group 2
Fixed-Dose Combination of Bisoprolol 5
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. Subjects must have uncontrolled essential hypertension with stable Coronary Artery Disease (CAD) having mean seated SBP more than 140 to 179 and DBP of more than 90 to 109 mmHg despite being on a stable regimen of dual antihypertensive agents including beta-blockers such as Bisoprolol 2.5 or 5mg (or equivalent dose of any other beta blocker) and calcium channel blockers such as Cilnidpine 10mg or Amlodipine 5mg or (any other calcium channel blocker at equivalent dose) for at least 4 weeks prior to study entry. 4. Must demonstrate a mean seated SBP more than 140-179 and DBP more 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 either 2 antihypertensive medications for at least 4 weeks prior to screening (participants who do not meet this criterion may be rescreened at the Investigators 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 non-pregnant and non- lactating females having a negative serum or urine pregnancy test.
Exclusion criteria
Exclusion criteria: 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 more than 40 kg per m2 at Screening. 3. Subjects previously sensitive to any of the ingredients of the investigational products. 4. Subjects with a known history of secondary or malignant hypertension. 5. Subjects with EF less than 40 percent as per Simpsons method 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 or 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 investigators clinical judgement. 10. Active malignancy requiring treatment at the time of visit 1. 11. Hepatic impairment (aspartate transaminase [AST] or alanine transaminase [ALT] more than 3x the upper limit of normal [ULN] or total bilirubin more than 2x ULN at time of enrolment). 12. Abnormal Serum Electrolytes (K 3.5 to 5.1 mmol per L). 13. Abnormal Thyroid Function Test [Normal range TSH 0.4 to 4.0 mIU per L, T4 0.8 to 2.8 ng per dL, T3 100 to 200 nanograms per deciliter (ng per dL)] 14. Renal Impairment (eGFR less than 60 mL per min per 1.73m2). 15. Type 1 Diabetes Mellitus or uncontrolled Type 2 DM (HbA1c more than 9.5 percent). 16. Subjects otherwise judged to be inappropriate for inclusion in the study by the investigators judgment. 17. Subjects with known alcohol or drug abuse history. 18. Subjects 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 from baseline in mean seated systolic blood pressure SeSBP Timepoint: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in mean seated systolic blood pressure SeSBPTimepoint: Week 4 and 8;Change from baseline in mean seated diastolic blood pressure SeDBPTimepoint: Week 4, 8 and 12;Percentage of the subjects achieved the target levels of clinical SeSBPTimepoint: Week 4, 8 and 12;Percentage of the subjects achieved the target levels of clinical SeDBPTimepoint: Week 4, 8 and 12;Proportion of responders after 12 weeks of dosingTimepoint: Week 12 | — |
Countries
India
Contacts
Public ContactMr Kartik Sahni
Insignia Clinical Services Pvt. Ltd.
Outcome results
None listed