Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
Intervention1: Fixed-Dose Combination of Nebivolol 2.5 mg, Cilnidipine 10 mg and Telmisartan 40 mg tablet, One Tablet Daily for 84 days.: One tablet daily 84 days.
Intervention2: Fixed-Dose Combinatio
Sponsors
Windlas Biotech Limited
Windlas Biotech Limited
Eligibility
Inclusion criteria
Inclusion criteria: Subjects will be included if all the inclusion criteria listed below are met: 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 less than 140 to 179 and DBP of less than 90 to 109 mmHg despite being on a stable regimen of dual anti-hypertensive agents including beta blockers 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 either 2 antihypertensive medications for at least 4 weeks prior to screening (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 non pregnant & non- lactating females having a negative serum/urine pregnancy test.
Exclusion criteria
Exclusion criteria: 1. Has a mean seated SBP more than180 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 than40 kg/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 percentage as per Simpson s 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/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]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/L). 13. Abnormal Thyroid Function Test [Normal range TSH = 0.4 to 4.0 mIU/L] 14. Renal Impairment (eGFR less than 60 mL/min per 1.73m2). 15. History of Type 1 Diabetes Mellitus or current uncontrolled Type 2 Diabetes Mellitus (HbA1c more than 9.5 percentage). 16. Subjects otherwise judged to be inappropriate for inclusion in the study by the investigator s 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 subject, 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 subject 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 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 subjects achieved the target levels of clinical SeSBP (Target level:Seated SBP less than 140 mm Hg)Timepoint: Baseline to Week 4,8 and 12;Percentage of the subjects achieved the target levels of clinical SeDBP (Target level :Seated DBP less than 90 mm Hg)Timepoint: Baseline to Week 4,8 and 12;Proportion of RespondersTimepoint: After 12 Weeks after 12 weeks of dosing (Responder rate defined as the proportion of subjects with decrease in diastolic BP by at least 10 mmHg). | — |
Countries
India
Contacts
Public ContactMr Kartik Sahni
Insignia Clinical Services
Outcome results
None listed