Mixed Dyslipidemia Clinical Trial
Official title:
An Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate Simvastatin 20 mg Plus Omacor 4g Compared to Simvastatin 20 mg Plus Placebo in Subjects With Mixed Dyslipidemia
Verified date | May 2008 |
Source | Provident Clinical Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The primary objective of this trial is to assess the continued efficacy of Omacor co-administered with simvastatin for lowering non-high-density lipoprotein cholesterol (non-HCL-C) levels.
Status | Active, not recruiting |
Enrollment | 13 |
Est. completion date | September 2009 |
Est. primary completion date | August 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 79 Years |
Eligibility |
Inclusion Criteria: - Must have met all relevant inclusion/exclusion criteria prior to and throughout the previous double-blind study (PRV-06009) - Must have completed the previous double-blind study to week 12. - Provide written informed consent and authorization for protected health information Exclusion Criteria: - Study drug compliance less than 50% in PRV-06009 - Any ongoing serious adverse event from PRV-06009 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Provident Clinical Research | Reliant Pharmaceuticals |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary efficacy endpoint will be the percent change in non-HDL-C from baseline (average of weeks -2, -1, and 0) of the PRV-06009 double-blind study to Week 6 of PRV-06009X | Week 6 | No | |
Secondary | The percent change in non-HDL-C from baseline (average of weeks -2, -1, and 0) of the PRV-06009 double-blind study to week 52 of PRV-06009X open-label treatment | 52 weeks | No | |
Secondary | The percent change in non-HDL-C from baseline (average of weeks -2, -1, and 0) of the PRV-06009 double-blind study to week 104 of PRV-06009X open-label treatment | 104 weeks | No |
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