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.
- Conditions
- Health Condition 1: I259- Chronic ischemic heart disease, unspecifiedHealth Condition 2: null- Secondary prophylaxis of ischemic heart disease
- Registration Number
- CTRI/2009/091/001022
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method o. 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 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. <br/ ><br>(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. <br/ ><br>(3)No. of tablets of isosorbide dinitrate taken by the patients during the study period of 4 weeks.Timepoint: 0,2 & 4 weeks.