Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
Intervention1: Fixed-Dose Combination (FDC) of Bisoprolol 5mg and Cilnidipine 10mg tablet: One Tablet daily for 84 days
Control Intervention1: Fixed-Dose Combination of Metoprolol Succinate ER 50mg an
Sponsors
Unique Pharmaceutical Laboratories (a Division of J. B. Chemicals & Pharmaceuticals Ltd.)
Unique Pharmaceutical Laboratories a Division of J B Chemicals Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female participants with age 18 years to 65 years (both inclusive) at the time of screening 2.Adult subjects who are capable of understanding and giving written informed consent and willing to comply with the study protocol 3.Subjects diagnosed with Essential Hypertension with the background of stable coronary artery disease (CAD) with mean seated SBP ranging between 140-180 mmHg and or mean seated DBP ranging between 90-110 mmHg. Mean seated BP is defined as the average of 3 seated BP measurements at any screening or re-screening visit. 4.Females of 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.
Exclusion criteria
Exclusion criteria: 1.Subjects previously sensitive to any of the ingredients of the fixed-dose combination under study or beta-blockers or angiotensin receptor blockers, 2.Subjects with clinically significant renal disorders Estimated glomerular filtration rate: less than 60 mL^min per 1.73 m2) Subjects with S. Creatinine values and S.BUN values more than equal to 1.5 times the upper limit of normal. Subjects with abnormal lab values of Na+, K+, Mg++ and Uric acid. [Normal range: Na+ = 135-145 mEq^L, K+ = 3.5-5.0 mmol^L, Mg++ = 1.8-2.2 mg^dL and Uric acid 3.5-7.2 mg^dL] 3.Subjects with past history or present symptoms of Bradycardia [Pulse rate less than 60bpm] at 2 out of 3 measurements either at Screening or Randomization 4.Subjects with hepatocellular insufficiency and in subjects with hepatic failure or active liver disease [abnormal Liver Function Test with values more than 2.5 times the upper limit of normal] 5.Subjects with clinically Endocrine system disorders Subjects with abnormal Thyroid Function Test (TSH). Subjects with Type 1 Diabetes Mellitus. 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. 6.Subjects with a known history of secondary or malignant hypertension, 7.Subjects with LVEF less than 40 percent on 2D Echo at Screening or Randomization (previous reports of upto 8 weeks is acceptable), 8.Any known cardiac disease or 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.) 9.Subjects with known significant respiratory or liver or kidney or neurological diseases or uncontrolled diabetes 10.Pregnant and lactating women or the women of child bearing age who are not practicing the effective means of contraception 11.Subjects otherwise judged to be inappropriate for inclusion in the study by the investigator s judgment 12.Subjects who will receive some other drug during the study besides that in the protocol that could alter the pharmacokinetic or pharmacodynamic profile of the study drug 13.Subjects with known alcohol or drug abuse 14.Subjects with known History of HIV, Hepatitis B and Hepatitis C 15.Hemodynamically unstable subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in mean seated systolic (SeSBP) blood pressureTimepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in mean seated diastolic (SeDBP) blood pressureTimepoint: 12 weeks;Reduction in mean seated systolic (SeSBP) and seated diastolic (SeDBP) bloodTimepoint: 4 weeks;Reduction in mean seated systolic (SeSBP) and seated diastolic (SeDBP) blood pressureTimepoint: 8 weeks;Percentage of the subjects achieving target clinical levels of mean seated systolic (SeSBP) blood pressure (target level: SeSBP less than 140 mm Hg)Timepoint: 4, 8 and 12 weeks;Percentage of the subjects achieving target clinical levels of mean seated diastolic (SeDBP) blood pressure (target level: SeDBP less than 90 mm Hg)Timepoint: 4, 8 and 12 weeks;Proportion of respondersTimepoint: 12 weeks;Reduction in mean heart rate compared to baselineTimepoint: 4, 8 and 12 weeks | — |
Countries
India
Contacts
Public ContactMr Kartik Sahni
Insignia Clinical Services Pvt. Ltd.
Outcome results
None listed