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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1500

Inclusion Criteria

1. Male or female aged = 18 years
2. Documented 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. If this is
not the case, an initial blood sample should be taken and analysed at the local laboratory
to confirm this. These results should be confirmed at Screening Visit 1.
3. Female subjects 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)
4. In good physical and mental health as determined by a physician on the basis of medical
history, physical examination and laboratory results
5. Read and understood the Subject Information Sheet and signed the Informed Consent
Form
At Visit 2/2.1 during Dietary Run-In subjects must be/have:
6. 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 subjects must have fulfilled the above
criteria and have:
7. 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
8. Pupils must dilate = 6mm.
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 subjects must not be/have:
1. Coronary heart disease (CHD) or CHD-risk factors comprised of:
1.1 Diabetes mellitus Type I or II
1.2 History 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
2. A body mass index (BMI) < 15 or > 35 kg/m2
3.A history or presence of:
1.1 Drug 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. For a definition of a unit of alcohol see section 9.11
1.2 Uncontrolled hypertension despite medical treatment (Stage 2 hypertension defined
as mean resting diastolic blood pressure > 100mmHg or mean resting systolic blood
pressure > 160mmHg)
1.3 Thyroid disease, particularly hyperthyroidism or subjects whose thyroid replacement
therapy was initiated within the last 3 months
1.4 HIV positive status, hepatitis B or C
1.5 Malignancy, except subjects whose malignancy has been diagnosed as Stage 1 basal
or squamous cell carcinoma
1.6 Heterozygous or homozygous familial hypercholesteroleamia or known Type III
hyperlipoproteinaemia (familial dysbetalipoproteinaemia)
1.7 Fibromyalgia, myopathy, rhabdomyolysis or unexplained muscle pain and/or
discontinuation of HMG-CoA reductase inhibitors due to myalgia
1.8 Trauma 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
1.9 A clinically significant food allergy that would prevent adherence to the specialised
diet
4. Any other serious disease or condition that might affect life expectancy or make it
difficult to successfully manage and monitor the subject according to the protocol
5. A known hypersensitivity or history of adverse reaction to atorvastatin or to TAK-475
6. Taken any excluded medication (see Section 9.10) in the 30 days prior to Screening Visit
1 or be planning to take any for the duration of the study
7. Taking part in another investigational study or have been participating in an
investigational study within the 30 days prior to Screening Visit 1
8. Unable to give written informed consent for any reason
9. An ALT or AST level > 2 times the ULN, active liver disease, jaundice (bilirubin >1.5
times the ULN) or serum creatinine > 135 µmol/l (1.5 mg/dl), CPK > 3 times the ULN.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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