NCT01068626

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2006

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2010

Completed
1 year until next milestone

Results Posted

Study results publicly available

March 2, 2011

Completed
Last Updated

August 24, 2015

Status Verified

August 1, 2015

Enrollment Period

2.4 years

First QC Date

February 12, 2010

Results QC Date

February 7, 2011

Last Update Submit

August 6, 2015

Conditions

Abdominal Obesity

Outcome Measures

Primary Outcomes (1)

  • Change in Visceral Adipose Tissue Area Measured by Computed Tomography.

    6 months

Secondary Outcomes (5)

  • Change in Subcutaneous Adipose Tissue Area

    6 months

  • Change in the Ratio Between Intra-abdominal and Subcutaneous Tissue Area Measured by CT.

    6 months

  • Change in Hepatic Fat Infiltration Measured by CT.

    6 months

  • Change in Body Weight

    6 months

  • Change in LDL

    6 months

Study Arms (2)

Rosuvastatin

ACTIVE COMPARATOR
Drug: Rosuvastatin

Placebo for Rosuvastatin

PLACEBO COMPARATOR
Drug: Placebo for rosuvastatin

Interventions

RosuvastatinDRUG

10 mg once daily

Also known as: Crestor®
Rosuvastatin
Placebo for rosuvastatinDRUG

once daily

Placebo for Rosuvastatin

Eligibility Criteria

Age40 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male patients between 40 and 65 years of age.
  • Abdominal obesity
  • Dyslipidemia
  • Written informed consent.

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Molecular and Clinical Medicine, Sahlgrenska Academy at University of Gothernburg

Gothenburg, 413 45, Sweden

Location

MeSH Terms

Conditions

Obesity, Abdominal

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Kristjan Karason
Organization
University of Gothenburg
kristjan.karason@gu.se
+46 31 342 7554

Study Officials

  • John-Olov Jansson, Prof

    Department of Endocrinology, University of Gothenburg

    STUDY CHAIR

  • Claes Ohlsson, Professor

    Department of Clinical Pharmocology, University of Gothenburg

    STUDY CHAIR

  • Anna Nilsson, MD, PhD

    Department of Endocrinology, University of Gothenburg

    STUDY CHAIR

  • Kristjan Karason, MD, PhD

    Department of Molecular and Clinical Medicine at University of Gothenburg

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2010

First Posted

February 15, 2010

Study Start

May 1, 2006

Primary Completion

October 1, 2008

Study Completion

December 1, 2008

Last Updated

August 24, 2015

Results First Posted

March 2, 2011

Record last verified: 2015-08

Locations

SE(1)