Phase 3
N=140
12-Month, Open-Label, Extension Study of LCP-AtorFen in Dyslipidemia
Dyslipidemia
Bottom Line
View on ClinicalTrials.gov: NCT00664859 ↗Enrolled (actual)
140
Serious AEs
5.0%
Results posted
Mar 2020
Primary outcome: Primary: Change in Non-HDL Cholesterol, HDL Cholesterol, TG Levels From Baseline to End of Treatment — -48.2; -43.6; -42.0; 2.6 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- LCP-AtorFen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Veloxis Pharmaceuticals
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Non-HDL Cholesterol, HDL Cholesterol, TG Levels From Baseline to End of Treatment |
-48.2; -43.6; -42.0; 2.6; 2.8; -29.6 | — |
| SECONDARY Change in LDL Cholesterol, VLDL, Total Cholesterol, Apo A-1, and Apo B From Baseline to End of Treatment |
-44.8; -39.3; -40.9; 2.1; 14; -33.6 | — |
Summary
The current study is designed to test the long-term (12-month) safety and efficacy of LCP-AtorFen, a combination of atorvastatin and fenofibrate, in patients with dyslipidemia
Eligibility Criteria
Inclusion Criteria
- Subject has successfully completed the double-blind study (LCP-AtorFen-2001; NCT00504829).
- Subject has confirmed his or her willingness to participate in this study after being informed of all aspects of the study by voluntarily signing and dating an informed consent form in accordance with Good Clinical Practice (GCP).
Exclusion Criteria
- Study drug compliance /=160 mm Hg systolic and/or >/=100 mm Hg diastolic.
- Symptoms of unexplained muscle pain, tenderness or weakness (i.e., signs indicative of possible myopathy), or any diagnosis of myopathy or rhabdomyolysis.
- Any clinically significant change in physical exam or electrocardiogram from Visit 2 to Visit 6 of the double-blind study.
- Any clinically significant change from Visit 1 to Visit 6 of the double-blind study in medical history including, but not limited to: a diagnosis of insulin-dependent diabetes mellitus (DM); poorly controlled DM; poorly controlled hypertension; significant renal, pulmonary, hepatic, biliary, or gastrointestinal disease; cancer (except non-melanoma skin cancer); and epilepsy.
- Unwilling to abstain from medications, supplements, ingredients and herbal therapies that were excluded in the double-blind study and continue to be excluded in the open-label study.
- Women who are pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential (not surgically sterilized between menarche and menopause) who are not using a medically approved method of contraception.
- Other exclusion conditions might apply.
Data sourced from ClinicalTrials.gov (NCT00664859). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.