Phase 2
N=25
ABT-335 (Choline Fenofibrate) Reverse Cholesterol Transport (RCT) Study
Dyslipidemia
Bottom Line
View on ClinicalTrials.gov: NCT00673881 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Apr 2011
Primary outcome: Primary: Mean Change in Calculated Low Density Lipoprotein Cholesterol — -22.7 mg/dL — p=0.0042
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- choline fenofibrate (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Radiant Research
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Calculated Low Density Lipoprotein Cholesterol |
-22.7 | 0.0042 sig |
| PRIMARY Mean Change in Plasma Triglycerides |
-138.0 | 0.0002 sig |
| PRIMARY Mean Change in High Density Lipoprotein Cholesterol |
-1.6 | NS |
| PRIMARY Total Cholesterol |
-54.0 | <0.0001 sig |
| SECONDARY Plasma Cholesterol Efflux |
— | — |
| SECONDARY Change in Plasma Cholesterol Ester Fractional Catabolic Rate (FCR) |
— | — |
| SECONDARY Percent Change in de Novo Cholesterol Synthesis |
— | — |
| SECONDARY Change in Neutral Sterol Excretion |
— | — |
| SECONDARY Change in Bile Acid Excretion |
— | — |
| SECONDARY Neutral Sterol Endogenous Excretion |
— | — |
| SECONDARY Endogenous Bile Acid Excretion |
— | — |
Summary
The objectives of the study are:
1. To evaluate the effect of ABT-335 (choline fenofibrate) on several parameters of RCT (reverse cholesterol transport) in men and post-menopausal women diagnosed with dyslipidemia (i.e., low high-density lipoprotein [HDL] cholesterol levels and elevated triglyceride [TG] concentrations).
2. To evaluate longitudinal changes in several parameters of RCT in subjects with low HDL.
3. To obtain pilot data for power calculations for subsequent comparative study.
Eligibility Criteria
Inclusion Criteria
- Male, non-smoker, 21 - 75 years of age inclusive.
- Female, non-smoker, 40 - 75 years of age inclusive.
- Post-menopausal women, as defined by lack of menses for at least 2 years and age > 55, OR history of documented bilateral surgical oophorectomy, confirmed with an elevated follicle-stimulating hormone (FSH) at screening.
- HDL concentration (≤ 50 mg/dl women, ≤ 40mg/dl men)
- TG concentration 150-500 mg/dl, inclusive
- Ability to give informed consent
Exclusion Criteria
- Subject has history of diabetes mellitus, active hepatitis, gall bladder disease, gastric bypass surgery, or clinically significant abnormalities on screening (prestudy) physical examination or laboratory tests.
- Screening laboratory tests with hematocrit 2X upper limit of normal, abnormal thyroid-stimulating hormone (TSH), fasting glucose ≥126 mg/dl.
- Renal impairment with creatinine clearance 14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor).
- Participation in another clinical trial or exposure to any investigational agent within 30 days before visit 1.
- Individual has a condition the Principal Investigator believes would interfere with his/her ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the subject at undue risk.
Data sourced from ClinicalTrials.gov (NCT00673881). 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.