osartan - Metoprolol XL Combination in Essential Hypertension Along with Type II Diabetes

Phase 3

Completed

• Conditions: Health Condition 1: null- Essential Hypertension Along with Type II Diabetes

• Registration Number: CTRI/2011/08/001937
• Lead Sponsor: Ipca Laboratories Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2013-08-30
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 158

Inclusion Criteria

To be eligible for inclusion, each patient must fulfill each of the following criteria at baseline / randomization:

� Patients with study related disease condition.

� Patients with essential hypertension

� Patients diagnosed of Type II diabetes

� The subject must agree to fully comply with study procedures and restrictions.

� The subject must willingly give informed consent.

Exclusion Criteria

� Patients with secondary hypertension.

� Patients with Type I diabetes mellitus.

� Patients with diastolic BP >= 110 mm Hg

� Patients with significant cardiovascular disease

� Patients with pulmonary diseases

� Patients with history of coronary heart disease or any other morbid condition with poor prognosis.

� Patients with abnormal renal and liver function

� Patients with electrolyte imbalance

� Patients with retinopathy or history of retinopathy except non-proliferative retinopathy.

� Patients with disease of blood or haematopoetic organs

� Patient with known history of diabetic ketoacidosis

� Previously diagnosed cases of HIV 1 OR HIV 2, Hepatitis B or C Viruses or syphilis infection.

� Patients with use of corticosteroid or chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs).

� Patients receiving insulin.

� Patients requiring 325 mg/day of aspirin, warfarin sodium, ticlopidine hydrochloride or any other drugs that affecting platelet function and coagulation.

� Patient having any concomitant medication, which may interact with action of study drugs.

� Patients with known history of hypersensitivity to losartan, metoprolol, ramipril or other similar drugs of same chemical class or any other ingredient of the study formulations or with history of severe allergic disease.

� Patients with a history of drug dependence, other substance abuse or excessive alcohol intake on habitual basis or have difficulty in abstaining for the duration of study.

� Known intravenous drug abusers

� Patients who have used another investigational agent/device or participated in a clinical trial within the last 30 days prior to enrollment

� Pregnant or lactating women.

� Women of childbearing potential not practicing contraception

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To demonstrate the comparable efficacy of losartan + metoprolol XL combination with losartan + ramipril with respect to mean fall in systolic and diastolic BP from baseline at the end of the therapyTimepoint: Day 0 and Day 84

Secondary Outcome Measures

Name	Time	Method
1. To compare the percentage of patients achieving the target goal blood pressure. (SBP 130 mm Hg and DBP 80 mm Hg) <br/ ><br>2. To assess the changes in microalbuminuria from baseline at the end of therapy in both the treatment groups. <br/ ><br>3. To assess the safety and tolerability of the test product in the study population <br/ ><br>Timepoint: 1. For perecentage of patients achieving goal BP: <br/ ><br>Day 84 <br/ ><br> <br/ ><br>2. For UAE Changes <br/ ><br>From Day 0 to Day 84 <br/ ><br> <br/ ><br>3. Safety and Tolerability <br/ ><br>From Day 0 - Day 84