A clinical trial to study the efficacy,safety and tolerability of Olmesartan Medoxomil 40mg + Amlodipine 10mg + Hydrochlorothiazide 25mg tablets in patient suffering from Hypertension.

An open label, non comparative and multicentric clinical study to evaluate the efficacy, safety and tolerability of Olmesartan Medoxomil 40mg + Amlodipine 10mg + Hydrochlorothiazide 25mg tablets in patient suffering from Hypertension

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/003051

Enrollment

200

Registered

2010-12-22

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Olmesartan Medoxomil 40mg + Amlodipine 10mg + Hydrochlorothiazide 25mg Tablets: Once daily for 12 weeks. Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients of either gender between the age group of 18 to 75 years. 2.Patients suffering from hypertension. (Systolic and Diastolic Blood Pressure more than 140/90mmHg respectively) 3.Written informed consent to participate to the trial.

Exclusion criteria

Exclusion criteria: 1.Patients with age of <18 or >75 years. 2.Pregnant or lactating woman. 3.History of hypersensitivity to the study drug or similar class of drug. 4.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. 5.Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the test drug(s), including cardiovascular, renal, pulmonary, hepatic, gastrointestinal, endocrine/metabolic, haematological/oncological, neurological and psychiatric diseases. 6.Patients with serum creatinine greater than 2.5 mg/dl. 7.Patients with raised SGPT and total bilirubin greater than 50% above the upper normal limits 8.Any clinical significant illness during the 4 weeks prior to day 1 of this study. 9.Maintenance therapy with any drug, or history of drug dependency, alcohol abuse, or serious neurological or psychological disease. 10.Participation in a clinical trial with an investigation drug within 30 days proceeding day one of this study. 11.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
1. Seated Systolic Blood Pressure 2. Seated Diastolic Blood PressureTimepoint: Day 1st, Week 2nd, Week 4th, Week 8th and Week 12th	—

Secondary

Measure	Time frame
Headache, Dizziness, Blurred vision, Nausea and Vomiting, Chest pain, Breathlessness.Timepoint: Day 1st, Week 2nd, Week 4th, Week 8th and Week 12th.	—

Countries

India

Contacts

Public ContactMr. Deepak Sohoni

Project Coordinator

deepaks@biosrl.com02228453582

Outcome results