Effect of Combination Therapy With Two Drugs (Colesevelam and Ezetimibe) in Patients With High Cholesterol

Daiichi Sankyo

Status and phase: Completed; Phase 4

Conditions: Hypercholesterolemia

Treatments: Drug: Ezetimibe; Drug: Simvastatin; Drug: Colesevelam Hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00185107

WEL-408

Details and patient eligibility

About

Assess the efficacy of WelChol® plus Zetia® in treating patients with high cholesterol

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-80 years of age, inclusive;
• A history of primary hypercholesterolemia

Exclusion criteria

• Any serious disorders including pulmonary, hepatic, renal, gastrointestinal (including clinically significant malabsorption), uncontrolled endocrine/ metabolic, hematologic/oncologic (within the last 5 years), neurologic and psychiatric diseases that would interfere with the conduct of the study or interpretation of the data;
• Hepatic dysfunction including biliary cirrhosis, unexplained persistent liver function abnormality, and pre-existing gallbladder disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind