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 available

• Conditions: Treatment of patients with primary dyslipidemia; MedDRA version: 7Level: PTClassification code 10058108

• Registration Number: EUCTR2004-000775-34-EE
• Lead Sponsor: Takeda Europe R&D Centre Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

At Screening Visit 1 in order to be eligible for enrolment patients must be/have:·

Male or female aged = 18 years.

History of dyslipidemia (fasting LDL-C levels = 160 mg/dL (4.15 mmol/L) and triglycerides < 400 mg/dL (4.52 mmol/L) within 30 days prior to screening. These results should be confirmed at screening

Female patients of child-bearing age must have undergone surgical sterilisation, hysterectomy, tubal ligation, bilateral oophorectomy or be post menopausal women (defined as amenorrhoea > 1yr due to menopause)·

In good physical and mental health as determined by a physician on the basis of medical history, physical examination and laboratory results·

Read and understood the Patient Information Sheet and signed the Informed Consent Form

At Visit 2/2.1 during the Dietary Run-In period patients must be/have:·Fasting LDL-C levels = 130 mg/dL (3.37 mmol/L) <190mg/dL (4.92mmol/L) and triglycerides < 400 mg/dL (4.52 mmol/L)At Randomisation Visit 3 in order to be randomised patients must have fulfilled the above criteria and have:·

A LOCS III assessment 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 colour less than 3.0
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

At Screening Visit 1 to enter the 6-week Dietary Run-In period the patients must not be/have: ·
Coronary heart disease (CHD) or CHD-risk factors comprised of:

oDiabetes mellitus Type I or IIoHistory or presence of myocardial infarction, angina pectoris, unstable angina, coronary angioplasty, coronary or peripheral arterial surgery (bypass graft), aortic aneurysm, transient ischaemic attacks or cerebrovascular accident·

A body mass index (BMI) < 15 or > 35 kg/m2·

A history or presence of:

oDrug abuse (defined as illicit drug use) or a history of alcohol abuse(defined as routinely consumes > 21 units of alcohol per week) within the 2 years previous to screening
oUncontrolled hypertension (Stage 2 hypertension defined as mean resting diastolic blood pressure > 100mmHg or mean resting systolic blood pressure > 160mmHg)
oUncontrolled hyper- or hypothyroidism or patients whose thyroid replacement therapy was initiated within the last 3 months
oHIV positive status, liver disease, hepatitis B or CoMalignancy, except patients whose malignancy has been diagnosed as Stage 1 basal or squamous cell carcinoma
oHeterozygous or homozygous familial hypercholesteroleamia or known Type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia)
oFibromyalgia, myopathy, rhabdomyolysis or unexplained muscle pain and/or discontinuation of HMG-CoA reductase inhibitors due to myalgia
oTrauma to the eye or eye irradiation, glaucoma, iritis, uveitis, prior intraocular surgery, laser surgery to the iris, retinal photocoagulation, or laser trabeculoplasty, corneal opacification or other medial opacities, or has received LASIK refractive surgery within 6 months prior to Screening Visit 1
oA clinically significant food allergy that would prevent adherence to the specialised diet ·

Any other serious disease or condition that might affect life expectancy or make it difficult to successfully manage and monitor the patient according to the protocol

oA known hypersensitivity or history of adverse reaction to atorvastatin or to TAK-475

oTaken any excluded medication (see Section 9.10) in the 30 days prior to the Screening Visit 1 or be planning to take any for the duration of the study

oTaking part in another investigational study or have been participating in an investigational study within the 30 days prior to the Screening Visit 1

oUnable to give written informed consent for any reason

oAn ALT or AST level > 2 times the ULN, active liver disease, jaundice (bilirubin >1.5 times the ULN) or serum creatinine > 135 mmol/l (1.5 mg/dl), CPK > 3 times the ULN.

Study & Design

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