CTRI/2009/091/000591CompletedPhase 3
A DOUBLE-BLIND, RANDOMIZED, CONTROLLED MULTICENTRE STUDY TO ASSESS THE EFFICACY AND SAFETY OF RAMIPRIL MR CAPSULES (PANACEA BIOTEC LTD) IN COMPARISON WITH CARDACE (AVENTIS PHARMA LIMITED INDIA) IN PATIENTS OF MILD TO MODERATE HYPERTENSIO
Panacea Biotec Ltd, New Delhi0 sites252 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 252
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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
- •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
- •?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.
Investigators
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