A clinical trial to study the effects of Atorvastatin + Ramipril + Aspirin + Metoprolol (as extended release) fixed dose combination capsules for secondary prophylaxis in patients with ischemic heart disease.

Phase 3

Completed

• Conditions: Chronic ischemic heart disease, unspecified, Secondary prophylaxis of ischemic heart disease,

• Registration Number: CTRI/2009/091/001022
• Lead Sponsor: Cadila Healthcare Ltd

Brief Summary

This study is an open label, multicentric study assessing the safety and efficacy of fixed-dose combination capsules of Atorvastatin 10mg + Ramipril 5mg + Aspirin 150mg + Metoprolol succinate 25mg (as extended release) once daily in the evening for 4 weeks for secondary prophylaxis in 100 patients with ischemic heart disease that will be conducted in one center only in India. The primary outcome measure will be the number of events of manifestations of ischemic heart disease experienced by the patients during the study period of 4 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-26
• Last Update Posted: 2018-10-27

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 1.Patients of either sex more than or equal to 18 years of age (No upper age limit was mentioned in our Protocol for this clinical trial).
• 2.Established diagnosis of ischemic heart disease.
• 3.Informed consent of the patient / relative.

Exclusion Criteria

• 1.Pregnancy & Lactation.
• 2.Patients with active liver disease or hepatic dysfunction indicated by AST or ALT levels  2.5 times the upper limit of normal.
• 3.Patients with history of myopathy or evidence of active muscle disease.
• 4.Patients with congestive heart failure (defined as New York Heart Association class III or IV heart failure).
• 5.Patients with 2nd or 3rd degree AV block, sick sinus syndrome or uncontrolled cardiac arrhythmias.
• 6.Patients with active peptic ulceration, hemophilia or hemorrhagic disorders.
• 7.Patients with unstable endocrine or metabolic diseases known to influence serum lipids and lipoproteins or known impairment of renal function.
• 8.Patients with any other serious concurrent illness or malignancy.
• 9.Patients with continuing history of alcohol and / or drug abuse.
• 10.Patients with known hypersensitivity to either of the contents of the combination.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
No. of events of manifestations of ischemic heart disease experienced by the patients during the study period of 4 weeks.	0,2 & 4 weeks.

Secondary Outcome Measures

Name	Time	Method
(1)The reduction in the systolic and diastolic blood pressure at the end of the treatment phase i.e. Week 4, as compared to the start of the treatment phase i.e., Week 0.	(2)The percent change in serum LDL cholesterol and other lipid parameters at the end of the treatment phase i.e., Week 4, as compared to the start of the treatment phase i.e., Week 0.

Trial Locations

Locations (4)

Government Medical College, Vadodara; 🇮🇳 Vadodara, GUJARAT, India

Mahatma Gandhi National Institute of Medical Sciences Jaipur; 🇮🇳 Jaipur, RAJASTHAN, India

S.P. Medical College and A.G. Hospitals, Bikaner.; 🇮🇳 Bikaner, RAJASTHAN, India

Shashwat Hospital & Research Centre, Ahmedabad; 🇮🇳 Ahmadabad, GUJARAT, India

Government Medical College, Vadodara

🇮🇳Vadodara, GUJARAT, India

Dr. Mahendra Parmar

Principal investigator

mcparmar1961@yahoo.co.in