Health Condition 1: null- MILD TO MODERATE HYPERTENSION
Conditions
Interventions
Intervention1: Ramipril MR Capsules: 2.5 mg, 5 mg, 10 mg
Control Intervention1: Cardace (Aventis Pharma): 1.25 mg, 2.5 mg, 5 mg
Sponsors
Panacea Biotec Ltd, New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects 18 years or more of either sex and is able to give written informed consent 2. The diastolic blood pressure is ≥90 mm of Hg and ≤109 mm of Hg and systolic blood pressure is ≥140 mm of Hg and ≤179 mm of Hg (European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC), 2007). 3. Is willing to discontinue current antihypertensive medications (if any) at the time of screening
Exclusion criteria
Exclusion criteria: 1. Inability to discontinue all prior antihypertensive medications 2. Pregnant or lactating women. Women of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception [which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner, during the study therapy. 3. Is taking or expected to take an excluded medication including antihypertensive agents, insulin or other agents that alter blood pressure, including: ? Tricyclic antidepressants ? Monoamine oxidase inhibitors ? Lithium ? Digoxin ? Phosphodiesterase type 5 inhibitors ? Amphetamines or their derivatives ? Chronically used (defined as more than 3 doses/week) common cold medications or non-steroidal anti-inflammatory, including aspirin greater than 325 mg/day or cyclooxygenase-2 inhibitors ? Systemic use of corticosteroids (topical or inhaled is acceptable) 4. Is hypersensitive to study medication or any of its excipients or the subject had history of angiodema with the use of ACE inhibitor 5. Has a recent history within the last 6 months of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack 6. Has secondary hypertension of any etiology (eg renovascular disease, pheochromocytoma, Cushing's syndrome) 7. Has renal dysfunction or disease with serum creatinine >2.5 mg/dL 8. Has known or suspected unilateral or bilateral renal artery stenosis 9. Has a previous history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug. (This criterion does not apply to those subjects with basal cell or stage-I squamous cell carcinoma of the skin) 10. Has uncontrolled diabetes mellitus 11. Has hyperkalemia as defined by the laboratory normal reference range at screening 12. Chronic use of salt substitutes containing potassium chloride, potassium supplements, extreme dietary restrictions 13. Has clinical laboratory evaluations (including biochemistry, hematology, and complete urinalysis) are not within the reference range for the testing laboratory at screening and the results are deemed clinically significant by the investigator 14. Has an alanine amino transferase level >3 times the upper limit of normal, active liver disease, or jaundice 15. Is currently participating in another investigational study or has participated in an investigational study within 30 days prior to screening 16. Has any other serious disease or condition that would compromise subject safety, might affect life expectancy, or make it difficult to successfully manage and follow the subject according to the protocol 17. Subjects with evidence of postural hypotension (defined as drop in >20 mg of Hg for systolic blood pressure and >10 mm of Hg for diastolic blood pressure after assuming the standing posture from supine or sitting position) 18. Subjects with history of persistent non productive cough which in the opinion of the investigator may be associated with use of ACE inhibitors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate that the reduction in mean sitting diastolic blood pressure (msDBP) with Ramipril MR Capsule (Panacea Biotec Ltd) when administered once daily is non inferior to Cardace (Aventis Pharma Limited India) when administered twice daily at the end of 12 weeks of study treatmentTimepoint: 12 weeks of study treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate that the reduction in mean sitting systolic blood pressure (msDBP) with Ramipril MR Capsule (Panacea Biotec Ltd) when administered once daily is non inferior to Cardace (Aventis Pharma Limited India) when administered twice daily at the end of 12 weeks of study treatmentTimepoint: 12 weeks of study treatment | — |
Countries
India
Contacts
Public ContactDr Arani Chatterjee
Outcome results
None listed