Trials / Completed
CompletedNCT00889226
Efficacy and Safety Study of Pitavastatin Compared to atoRvastatin in Type 2 dIabeTes Mellitus With Hypercholesterolemia
A Randomized, Open Label, Dose Titration Study to Evaluate the Efficacy and Safety of Pitavastatin Compared to atoRvastatin in Type 2 dIabeTes Mellitus With Hypercholesterolemia
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 161 (actual)
- Sponsor
- JW Pharmaceutical · Industry
- Sex
- All
- Age
- 25 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
A randomized, open label, dose titration study to evaluate the efficacy and safety of Pitavastatin compared to atorvastatin in Type 2 Diabetes Mellitus with hypercholesterolemia
Detailed description
To evaluate the effect of pitavastatin compared to atorvastatin on the change of Lipid profiles, ApoA1, ApoB, adiponectin and baPWV as a marker of atherosclerosis in Type 2DM .
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pitavastatin | Drug: Pitavastatin 2mg daily for 8wks after initial visit. After assessment of LDL-C \<100mg/dL at 8wks → Dose adjustment Yes → 2mg daily for second 8wks No → 4mg daily for second 8wks |
| DRUG | Atorvastatin | Drug: Atorvastatin 10mg daily for 8wks after initial visit. After assessment of LDL-C \<100mg/dL at 8wks → Dose adjustment Yes → 10mg daily for second 8wks No → 20mg daily for second 8wks |
Timeline
- Start date
- 2008-04-01
- Primary completion
- 2009-05-01
- Completion
- 2010-01-01
- First posted
- 2009-04-28
- Last updated
- 2019-09-17
- Results posted
- 2019-09-17
Source: ClinicalTrials.gov record NCT00889226. Inclusion in this directory is not an endorsement.