Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY EAST)

Phase 3

Completed

• Conditions: Health Condition 1: null- HypercholesterolemiaHealth Condition 2: E780- Pure hypercholesterolemia

• Registration Number: CTRI/2016/07/007068
• Lead Sponsor: Sanofi Synthelabo India Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-06-11
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 112

Inclusion Criteria

Patients with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who are not adequately controlled with a maximally tolerated daily dose of statin.

For details Including area please see the Protocol.

Exclusion Criteria

Main Exclusion Criteria

E01. Patients without established CHD or CHD risk equivalents

E02. LDL-C 70 mg/dL (1.81 mmol/L) at the screening visit (Week -3) in

patients with history of documented CV disease

E03. LDL-C 100 mg/dL (2.59 mmol/L) at the screening visit (Week -3)

in patients without history of documented CV disease

NOTE â?? Cardiovascular disease (CVD) is defined as CHD, ischemic stroke or

peripheral arterial disease (PAD) as described in Section 7.1

E04. Change in statin dose or dose regimen from screening to

randomization

E05. Currently taking a statin other than atorvastatin, rosuvastatin or

simvastatin

E06. Atorvastatin, rosuvastatin or simvastatin is not taken daily or not

taken at a registered dose

E07. Daily doses above atorvastatin 80 mg, rosuvastatin 20 mg or

simvastatin 40 mg

E08. Use of cholesterol absorption inhibitor (ie, ezetimibe), omega-3 fatty

acid (at doses >=1000 mg daily), nicotinic acid, fibrates, bile

acid-binding sequestrant, or red yeast rice products in the past

4 weeks prior to screening visit (Week -3)

E09. Fasting serum triglycerides 400 mg/dL (4.52 mmol/L) at the screening period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified