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.

An open label multicentric study to assess the efficacy and safety of Atorvastatin + Ramipril + Aspirin + Metoprolol (as extended release) fixed dose combination capsules for secondary prophylaxis in patients with ischemic heart disease.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/001022

Enrollment

100

Registered

2009-12-18

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

Health Condition 1: I259- Chronic ischemic heart disease, unspecified Health Condition 2: null- Secondary prophylaxis of ischemic heart disease

Interventions

Intervention1: 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 Control Inte

Eligibility

Inclusion criteria

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

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. 11.Participation in another clinical trial in the past 3 months.

Design outcomes

Primary

Measure	Time frame
No. of events of manifestations of ischemic heart disease experienced by the patients during the study period of 4 weeks.Timepoint: 0,2 & 4 weeks.	—

Secondary

Measure	Time frame
(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. (3) No. of tablets of isosorbide dinitrate taken by the patients during the study period of 4 weeks.Timepoint: 0,2 & 4 weeks.	—

Measure

Time frame

(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. (3) No. of tablets of isosorbide dinitrate taken by the patients during the study period of 4 weeks.Timepoint: 0,2 & 4 weeks.

—

Countries

India

Contacts

Public ContactDr Ravindra Mittal

r.mittal@zyduscadila.com07926868926

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026