Health Condition 1: I798- Other disorders of arteries, arterioles and capillaries in diseases classified elsewhere
Conditions
Interventions
Intervention1: Fixed-Dose Combination of Bisoprolol 5 mg and Cilnidipine 10 mg tablet: Subjects will be instructed to take one tablet of the test in morning one (1) hour before or two to three (2-3) h
Sponsors
Windlas Biotech Limited
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 associated with stable coronary artery disease (CAD) with SBP ranging between 140-180 mmHg and/or DBP ranging between 90-110 mmHg 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 are as below Estimated glomerular filtration rate is less than 60 mL per min per 1.73 m2) Subjects with S. Creatinine values and S.BUN values greater 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+ is equal to 135 to 145 mEq per L and K+ is equal to 3.5 to 5.0 mmol per L, Mg++ is equal to 1.8 to 2.2 mg per dL and Uric acid 3.5 to 7.2 mg per dL 3. 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 4. Subjects with clinically Endocrine system disorders are 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 5. Subjects with a known history of secondary or malignant hypertension. 6. Subjects with EF less than 40 percent as per Simpsonâ??s method on 2D Echo. 7. Any known cardiac disease or disorder in which any of the study medication is contraindicated (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.) 8. Subjects with known significant respiratory or liver or kidney or neurological diseases or uncontrolled diabetes, 9. Pregnant and lactating women or the women of child bearing age who are not practicing the effective means of contraception, 10. Subjects otherwise judged to be inappropriate for inclusion in the study by the investigatorâ??s judgment. 11. 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, 12. Subjects with known alcohol or drug abuse. 13. Subjects with known History of HIV, Hepatitis B and Hepatitis C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean reduction in systolic and diastolic blood pressure measured in sitting positionTimepoint: From Baseline to week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Mean reduction in systolic and diastolic blood pressure measured in sitting position compared to baseline 2.Percentage of the subjects achieved the target levels of clinical BP among hypertensive subjects (target level: SeSBP less than 140 mm Hg) 3.Percentage of the subjects achieved the target levels of clinical BP among hypertensive subjects (target level: SeDBP less than 90 mm Hg) 4.Proportion of responders after 12 weeks of dosing (Responder rate defined as the proportion of subjects with decrease in diastolic BP by at least 10 mmHg) 5.Reduction in mean heart rate compared to baseline Timepoint: 1.Compared to baseline after 4 and 8 weeks 2.After 4, 8 and 12 weeks 3.After 4, 8 and 12 weeks 4.After 4, 8 and 12 weeks 5.Proportion of responders after 12 weeks of dosing 6.After 4, 8 and 12 weeks | — |
Countries
India
Contacts
Public ContactMr Umakant Ghodke
Windlas Biotech Limited
Outcome results
None listed