A clinical trial to study the effects of combination of atorvastatin and ezetemibe and compare it with atorvastatin only

A randomized double blind study to evaluate the lipid modifying, anti-inflammatory, antioxidant efficacy and tolerability of combination of atorvastatin and ezetimibe versus atorvastatin in patients with dyslipidemia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000003

Enrollment

Registered

2010-02-09

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: Fixed dose combination of atorvastatin and ezetimibe: one tablet containing 10 mg of each drug to be taken once daily for 4 weeks Control Intervention1: Atorvastatin: 10 mg tablet once

Eligibility

Inclusion criteria

Inclusion criteria: - Patient of either sex of age 18-70 years - Fasting LDL-C > or = 100 mg/dl in patients with CHD or CHD risk equivalents (Diabetes mellitus/ Peripheral arterial disease/ Carotid artery disease/ Abdominal aortic aneurysm) or Fasting LDL-C > or = 130 mg/dl in patients with > or = 2 major risk factors for development of CHD having 10-20% ten year absolute CHD risk and on therapeutic lifestyle changes (TLC) for 3 months - Patient taking low dose atorvastatin (10 mg) OD or patient not taking any hypolipidemic drug - Able to provide written informed consent

Exclusion criteria

Exclusion criteria: - Fasting serum triglyceride (TG) level &#8805;350 mg/dl - Medical history of systemic infection within 6 weeks of study initiation - Medical history of unstable angina, myocardial infarction, heart failure or stroke within 3 months of the study - Uncontrolled hypertension (systolic blood pressure >160 mm Hg and/or diastolic blood pressure >100 mm Hg) - Uncontrolled diabetes mellitus (FBS > 300 mg/dl in patients with diabetes) - ALT and AST > 2 x upper limit of normal - Impaired renal function (creatinine > or = 2.0 mg/dl) - Suffering from malabsorption syndrome or inflammatory bowel disease - Pregnancy/Lactation - Alcoholism - Patients on drugs that can increase the incidence of statin induced myopathy - Patient on chronic anti-inflammatory or antioxidant drugs within 6 weeks of study initiation

Design outcomes

Primary

Measure	Time frame
Reduction in LDL-C between two groupsTimepoint: 1. At baseline 2. At post treatment after 4 weeks	—

Secondary

Measure	Time frame
1. Serum sICAM 2. Serum hsCRP 3. Serum oxidized LDL 4. Adverse eventsTimepoint: 1. At Baseline 2. After 4 weeks of treatment	—

Countries

India

Contacts

Public ContactBiswa Mohan Padhy

AIIMS

drbisu7@gmail.com011-265593284

Outcome results