Phase 3
Completed N=59
Rosuvastatin in Visceral Adiposity
Source: ClinicalTrials.gov NCT01068626 ↗Enrolled (actual)
59
Serious AEs
6.8%
Results posted
Mar 2011
Primary outcomePrimary: Change in Visceral Adipose Tissue Area Measured by Computed Tomography. — -1.5; 2.8 cm2
Summary
The purpose of this study is to investigate whether 6 months treatment with the cholesterol-lowering drug rosuvastatin may reduce visceral fat tissue in obese middle aged men.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Visceral Adipose Tissue Area Measured by Computed Tomography. |
-1.5; 2.8 | — |
| SECONDARY Change in Subcutaneous Adipose Tissue Area |
10; 1 | — |
| SECONDARY Change in the Ratio Between Intra-abdominal and Subcutaneous Tissue Area Measured by CT. |
-0.02; 0.01 | — |
| SECONDARY Change in Hepatic Fat Infiltration Measured by CT. |
0; -2 | — |
| SECONDARY Change in Body Weight |
0.2; 0.5 | — |
| SECONDARY Change in LDL |
-1.4; -0.1 | — |
Eligibility Criteria
Inclusion Criteria
- Male patients between 40 and 65 years of age.
- Abdominal obesity
- Dyslipidemia
- Written informed consent.
Exclusion Criteria
- Uncontrolled hypertension
- Diabetes mellitus
- Severe liver disease
- Severely reduced renal function
- Uncontrolled endocrine disorders
- History of or ongoing malignant disease
- Patients with known myopathic disease
- Recent alcohol or drug abuse
- Weight loss or weight gain during the three months prior to screening.
- Ongoing treatment with statins
- Ongoing treatment with calcineurin-inhibitors
- Ongoing treatment with anti-inflammatory drugs
- Received an investigational drug within 30 days prior to screening.
- Strong clinical indication for statin treatment
- In the Principal Investigator's opinion, the patient has other clinically significant cardiac, oncologic, neurologic or psychiatric disease that could be adversely affected by Study participation.
- For any reason the patient is considered by the Principal Investigator to be an unsuitable candidate to participate in the Study.
Data sourced from ClinicalTrials.gov (NCT01068626). 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. Informational only — not medical advice.