Trials / Completed
CompletedNCT00510809
Effect of Policosanol as Monotherapy and Adjunctive to Statin Therapy
Safety and Efficacy of Policosanol Monotherapy and When Added to Chronic Statin Therapy: A Pilot Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 54 (actual)
- Sponsor
- James Backes, PharmD · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
To determine the effects of policosanol on the cholesterol profile.
Detailed description
The primary objectives of this study are to determine the changes in the lipid profile \[LDL-C, HDL-C, triglycerides, total cholesterol\] and the emerging risk factor, Lp(a), when policosanol is added to statin therapy. Additionally, one more primary objective is to evaluate the safety of the combination regimen.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Policosanol | Policosanol 20 mg daily |
| OTHER | Placebo | Placebo daily |
| DRUG | Policosanol Plus Already In Use Statin Therapy | Policosanol 20 mg daily Statin Therapy |
Timeline
- Start date
- 2007-07-01
- Primary completion
- 2010-03-01
- Completion
- 2010-05-01
- First posted
- 2007-08-02
- Last updated
- 2015-10-08
- Results posted
- 2012-07-20
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00510809. Inclusion in this directory is not an endorsement.