CTRI/2011/06/001820
Completed
Phase 3
Clinical Study to assess the efficacy and safety of fixed dose combination of S-Amlodipine besilate, Olmesartan medoxomil and Hydrochlorothiazide tablets in hypertension - SAOH
Emcure Pharmaceuticals Ltd Pune0 sites200 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Emcure Pharmaceuticals Ltd Pune
- Enrollment
- 200
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female patients between 18\-65 years of age, Subjects diagnosed with essential hypertension not controlled on monotherapy or two drug therapy or newly diagnosed Stage II hypertensives, Subject willing to give written informed consent and willing to comply with study protocol
Exclusion Criteria
- •Subjects previously sensitive to any of the ingredients of the fixed dose combination under study or calcium channel blockers or angiotensin receptor blockers or thiazide diuretic, Subjects with history of secondary or malignant hypertension, Patients with known significant respiratory/liver/kidney/neurological diseases / uncontrolled diabetes, Patients with evidence of any cardiac arrhythmia on ECG, Pregnant and lactating women or the women of child bearing age who are not practicing the effective means of contraception, Patients who will receive some other drug during the study besides that in the protocol that could alter the pharmacokinetic/ pharmacodynamic profile of the study drug, Patients with known alcohol or drug abuse, Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study
Outcomes
Primary Outcomes
Not specified
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