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

Phase 3

Completed

Conditions: In patients suffering from Hypertension

Registration Number: CTRI/2010/091/003051

Lead Sponsor: Vapi Care Pharma Pvt Ltd

Brief Summary: This is an open label, non comparative, multicentric clinical trial to study the efficacy, safety and tolerability of Olmesartan Medoxomil 40mg + Amlodipine 10mg + Hydrochlorothiazide 25mg tablets in patients suffering from Hypertension. This trial will be conducted on 200 patients and it has four centres. The primary outcome measures are : Seated systolic blood pressure and Seated diastolic blood pressure. The secondary outcome measures are: Headache, Dizziness, Blurred vision, Nausea and Vomiting, Chest pain and Breathlessness. Both the primary outcome measures and secondary outcome measures will be assessed on Day 1st, week 2nd, Week4th, Week 8th and Week 12th.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 200

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

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.

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Seated Systolic Blood Pressure2. Seated Diastolic Blood Pressure	Day 1st, Week 2nd, Week 4th, Week 8th and Week 12th

Secondary Outcome Measures

Name	Time	Method
Headache, Dizziness, Blurred vision, Nausea and Vomiting, Chest pain, Breathlessness.	Day 1st, Week 2nd, Week 4th, Week 8th and Week 12th.

Trial Locations

Locations (4): Apex Superspeciality Hospital
🇮🇳
Aurangabad, BIHAR, India
C.U Shah Medical Center
🇮🇳
C.J, Hospital,Surendranagar, India
Pirmashayakh Sarvjanik Hospital
🇮🇳
India
Shree Venkatesha Hospital and Polyclinic
🇮🇳
Nallasopara, (W)-, India
Apex Superspeciality Hospital
🇮🇳Aurangabad, BIHAR, India
Dr. Anand Nikalje
Principal investigator
anandnikalje@rediffmail.com