Health Condition 1: I10- Essential (primary) hypertension Health Condition 2: null- Hypertension
Conditions
Interventions
Intervention1: Olmesartan Medoxomil + Amlodipine Besilate + Hydrochlorothiazide Capsules: once daily for 3 months.
Control Intervention1: Olmesartan medoxomil & hydrochlorothiazide tablets: once dail
Sponsors
Ajanta Pharma Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients with Hypertension. 2.Written informed consent to participate to the trial.
Exclusion criteria
Exclusion criteria: Males or females, <18 or >60 years of age History of hypersensitivity to the study drug or similar class of drug. Significant history or presence of gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medications. Patients with serum creatinine greater than 2.5 mg/dl. Patients with raised SGPT and total bilirubin greater than 50% above the upper normal limits Any clinical significant illness during the 4 weeks prior to day 1 of this study. Maintenance therapy with any drug, or history of drug dependency, alcohol abuse, or serious neurological or psychological disease. Participation in a clinical trial with an investigation drug within 30 days proceeding day one of this study. Use of enzyme-modifying drugs within 30 days prior to day 1 of this study. Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seated Systolic Blood Pressure Seated Diastolic Blood Pressure Timepoint: Day 1, 1st month,2nd month & 3rd Month | — |
Secondary
| Measure | Time frame |
|---|---|
| Global AssesmentTimepoint: 3rd month;Headaches, Dizziness, Blurred vision, Nausea and Vomiting, Chest Pain, BreathlessnessTimepoint: Day 1, 1st month,2nd month & 3rd Month | — |
Countries
India
Contacts
Public ContactDr Shailesh Singh
Ajanta Pharma Ltd, Advent
Outcome results
None listed