A double-blind, randomised, parallel group study to evaluate the safety, tolerability and efficacy of TAK-475 alone or co-administered with atorvastatin in patients with primary dyslipidemia

Not Applicable

• Conditions: -E785 Hyperlipidaemia, unspecified; Hyperlipidaemia, unspecified; E785

• Registration Number: PER-080-04
• Lead Sponsor: TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-12-28
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• Be men or women of> 18 years of age.
• Having a history of dyslipidemia (fasting LDL-C levels> 160 mg / dL (4.15 mmol / 1) and triglycerides of <400 mg / dL (4.52 mmol / L) within 30 days prior to prescreening. Confine yourself in the preselection.
• Patients of reproductive age should have undergone surgical sterilization, hysterectomy, tubal ligation, bilateral oophorectomy or be postmenopausal (defined as amenorrhea of> 1 year due to menopause).
• Have a good physical and mental health determined by a doctor according to medical history, physical examination and laboratory results
• Have read and understood the Patient Information Sheet and signed the Informed Consent Form
• They should have fasting LDL-C levels of> 130 mg / dl (3.37 mmoIA) <190 mg / dl (4.92 mmol / 1) and triglycerides of <400 mg / dl (4.52 mmol / L)
• Have an assessment according to the lens opacity classification system (LOCS lE) of nuclear opalescence less than or equal to 3.0, cortical cataract less than or equal to 2.0, posterior subcapsular cataract less than or equal to 1.0, and nuclear color less than 3.0

Exclusion Criteria

• Presenting coronary heart disease or risk factors for coronary heart disease that include: Diabetes mellitus type I or E, history or presence of myocardial infarction, angina pectoris, unstable angina, coronary angioplasty, coronary or peripheral arterial surgery (bypass graft), aortic aneurysm, transient ischemic attacks or stroke
• Have a body mass index (BMI) of <15 or> 35 kg / m2
• Having a background or presence of:
o Drug abuse (defined as the use of illicit drugs) or a history of alcohol abuse (defined as the routine consumption of> 21 units of alcohol per week) within 2 years prior to prescreening
o Presenting uncontrolled hypertension (stage 2 hypertension, defined as resting mean diastolic blood pressure of> 100 mm Hg or mean resting systolic blood pressure of> 160 mm Hg)
o Presenting hyperthyroidism or uncontrolled hypothyroidism or being patients whose thyroid replacement therapy has begun within the last 3 months
o Have a positive HIV status, liver disease, hepatitis B or C
o Present a malignancy (tumor), except for patients whose malignancy has been diagnosed as a basal or squamous cell carcinoma of Stage 1
o Presenting heterozygous or homozygous familial hypercholesterolemia or known type III hyperlipoproteinemia (familial dysbetalipoproteinemia)
o Present fibromyalgia, myopathy, rhabdomyolysis or unexplained muscle pain and / or discontinuation of HMG-CoA reductase inhibitor medications due to the presence of myalgia
o Having suffered trauma or ocular radiation, glaucoma, iritis, uveitis, previous intraocular surgery, laser surgery for the iris, retinal photocoagulation or laser trabeculoplasty, corneal opacification or other media opacities, or having undergone LASIK refractive surgery within the 6 months prior to the Pre-selection Visit 1
o Having a clinically significant food allergy that could prevent compliance with the special diet
• Any other serious illness or disorder that may affect the life expectancy or hinder the proper management and control of the patient according to the protocol. Presenting hypersensitivity or having a history of adverse reaction to atorvastatin or TAK-475.
• Have taken any excluded medication (refer to Section 9.10) within 30 days prior to Prescreening Visit 1 or have plans to take any during the study
• To be participating in another research study or to have participated in a research study within 30 days prior to the Pre-selection Visit 1
• Failure to grant the Informed Consent in writing for any reason
• Have a level of ALT or AST of> 2 times the upper limit of normal (ULN), active liver disease, jaundice (bilirubin> 1.5 times the upper limit of normal), or serum creatinine> 135 mmol / 1 (1.5 mg / dL), creatine phosphokinase (CPK)> 3 times the upper limit of normal.

Study & Design

• Study Type: Interventional
• Study Design: Not specified