PER-108-09Completed未知
A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Evaluate the Long-term Efficacy, Safety and Tolerability of ERN/LRPT in Patients With Dyslipidemia
MERCK SHARP & DOHME PERU S.R.L.,0 sites0 target enrollmentStarted: November 17, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 75 (—)
Inclusion Criteria
- •The patient is male or female> 18 to <75 years of age on the day of signing the informed consent.
- •The patient understands the study procedures, the available alternative treatments, the risks involved in the study and voluntarily agrees to participate by signing an informed written consent.
- •The patient is male or female with a low probability of conceiving
Exclusion Criteria
- •The patient is pregnant, breastfeeding or expecting to conceive during the study including follow-up at 14 days after the study.
- •The patient has a history of malignant neoplasms <5 years before signing the informed consent, except for basal cell or squamous cell skin cancer or cervical cancer in situ properly treated.
- •The female patient is waiting to donate eggs during the study, including follow-up at 14 days or a male patient expects to donate sperm during the study, including follow-up at 14 days.
- •The patient has a history or current evidence of laboratory conditions, treatment or abnormalities that could confuse the results of the study, interfere with the patient´s participation during the entire period of the study, or do not keep the best interests for the patient´s participation.
- •The patient is unlikely to comply with the study procedures, keep appointments or are planning to move during the study.
- •The patient currently participates or has participated in a study with a research compound (non-lipid modification) in a period of 30 days before Visit 1, or a lipid modification compound (in research or commercialized) in a period of 6 weeks before Visit 1.
- •The patient has donated and / or received blood
- •At the time of signing the informed consent, the patient is a consumer of recreational or illegal drugs or has had a recent history (last year) of drug or alcohol abuse.
Investigators
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