A Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of TAK-475100 mg or Placebo When Co-Administered With High Dose Statin Therapy inSubjects With Primary HypercholesterolemiaAmended to evaluate TAK-475 50 mg during the Open Label Extensio

• Conditions: Treatment of patients with primary hypercholesterolemia currently taking atorvastatin (80mg), simvastatin (80mg) or rosuvastatin (40mg); MedDRA version: 8Level: PTClassification code 10058108

• Registration Number: EUCTR2005-004876-19-SE
• Lead Sponsor: Takeda Global R&D Centre (Europe) Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-24
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Adult male or female subjects (non-pregnant and non-lactating) who are at least 18 years of age, who meet the following lipid criteria:

• Prior to Randomization, the subject must have a mean LDL-C =100 mg/dL (2.59 mmol/L) for 2 consecutive samples (at least 1 week apart). The difference between the two individual LDL-C values must not exceed 15% of the higher value

• Prior to Randomization, the subject must have mean triglycerides =400 mg/dL (4.52 mmol/L) for 2 consecutive samples (at least 1 week apart). The upper value for either sample must be =450 mg/dL (5.1 mmol/L)

The subject must be taking the highest recommended dose of an HMG-CoA reductase inhibitor once daily for at least 4 weeks prior to Visit 1. Subjects who are on a stable regimen of ezetimibe, in addition to their HMG-CoA reductase inhibitor will be allowed to participate in the study while continuing the ezetimibe.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects who meet any of the following criteria will not qualify for entry into the study:

• if female, are pregnant, lactating, intend to become pregnant during the course of the study, or are unwilling to use acceptable contraception for the course of the study

• have elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (>1.5 times the upper limit of normal [ULN]), active liver disease, jaundice, or a history of liver disease

• has serum creatinine >133 mmol/L (1.5 mg/dL);

• have elevated creatine phosphokinase (>3 times ULN);

• has diabetes, with an HbA1c >8% at Visit 1;

• have a history of myocardial infarction, unstable angina, transient ischemic attacks,
cerebrovascular accident, percutaneous coronary intervention, coronary or peripheral arterial surgery (bypass graft surgery) in the 6 months prior to Visit 1;

• have fibromyalgia, myopathy, rhabdomyolysis or unexplained muscle pain;

• have a known hypersensitivity or history of adverse reaction to atorvastatin, rosuvastatin, or simvastatin;

• has inflammatory bowel disease or any other malabsorption syndrome or have had gastric bypass or another surgical procedure for weight loss;

• have uncontrolled hypertension despite medical treatment (defined as mean resting diastolic blood pressure >100 mm Hg or mean resting systolic blood pressure >160 mm Hg) at Visit 1.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified