NL-OMON31031
Not yet recruiting
Phase 3
A Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Lapaquistat Acetate 50 mg versus Placebo in Subjects with Hypercholesterolemia, With an Optional Open-Label Extension - TAK-475-306 study in hypercholesterolemia, with open-label extension
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- elevated cholesterol
- Sponsor
- Takeda
- Enrollment
- 71
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. The subject is a male or female and at least 18 years of age.
- •2\. A female subject of childbearing potential who is sexually active agrees to use adequate contraception from screening throughout the duration of the study and for 30 days following the last dose. Women NOT of child bearing potential are defined as those who have been surgically sterilized (hysterectomy, oophorectomy, tubal ligation) or who are postmenopausal (defined as at least 2 years since last regular menses). Acceptable methods of contraception are defined in Section 9\.1\.10 Contraception and Pregnancy Avoidance Procedure.
- •3\. The subject is capable of understanding and complying with protocol requirements.
- •4\. The subject or the subject\*s legally acceptable representative signs a written informed consent form prior to the initiation of any study procedures.
- •5\. Prior to Randomization, the subject has a mean LDL\-C \*130 mg/dL (3\.36 mmol/L) and \*190 mg/dL (4\.92 mmol/L) for 2 consecutive samples (at least 1 week apart). The difference between the 2 individual LDL\-C values must not exceed 15% of the higher value.
- •6\. Prior to Randomization, the subject has mean TG \<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\.08 mmol/L).
- •7\. The subject is willing and able to comply with a standardized diet (TLC or equivalent).
Exclusion Criteria
- •1\. The subject has an ALT or AST level \>2 times the upper limit of normal (ULN), identified during screening (eg, from the V1 blood sample). If a repeat test is \*2 times ULN then contact the Medical Monitor for consideration of inclusion \- See Section 9\.3\.1
- •2\. The subject has a serum creatinine \>133 mmol/L (\>1\.5mg/dL), identified during screening (eg, from the V1 blood sample).
- •3\. The subject has a CK \>3 times the upper limit of normal (ULN), identified during screening (eg, from the V1 blood sample). If a repeat test is \*3 times the ULN then contact the Medical Monitor for consideration of inclusion \- See Section 9\.3\.1
- •4\. The subject has active liver disease or jaundice.
- •5\. The subject has taken any fibrates within 42 days of Visit 1 or any lipid\-lowering therapy for at least 30 days prior to Screening (Visit 1\). (See Excluded Medications 7\.3\)
- •1\. The subject has an ALT or AST level \>2 times the upper limit of normal (ULN), identified during screening (eg, from the V1 blood sample). If a repeat test is \*2 times ULN then contact the Medical Monitor for consideration of inclusion \- See Section 9\.3\.1
- •2\. The subject has a serum creatinine \>133 mmol/L (\>1\.5mg/dL), identified during screening (eg, from the V1 blood sample).
- •3\. The subject has a CK \>3 times the upper limit of normal (ULN), identified during screening (eg, from the V1 blood sample). If a repeat test is \*3 times the ULN then contact the Medical Monitor for consideration of inclusion \- See Section 9\.3\.1
- •4\. The subject has active liver disease or jaundice.
- •5\. The subject has taken any fibrates within 42 days of Visit 1 or any lipid\-lowering therapy for at least 30 days prior to Screening (Visit 1\). (See Excluded Medications 7\.3\)
Outcomes
Primary Outcomes
Not specified
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