- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00654446
IIIb 6 Week Open Label Multicentre Rosuvastatin & Simvastatin
March 13, 2009 updated by: AstraZeneca
A 6-wk Open-Label, Randomised, Multicentre, Phase IIIb, Parallel-Group Study, Which Describes the Renal Effects of the Lipid-Regulating Agents Rosuvastatin and Simvastatin in the Treatment of Sub's With Fredrickson Type IIa & Type IIb Dyslipidaemia, Inc. Heterozygous Familial Hypercholesterolaemia
The purpose of this study is to assess the effects on the kidney of rosuvastatin and simvastatin in subjects with Fredrickson Type IIa & Type IIb Dyslipidaemia
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment
442
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Fasting low density lipoprotein level as defined by the protocol.
- Fasting triglyceride level as defined by the protocol.
Exclusion Criteria:
- The use of lipid lowering drugs or dietary supplements after Visit 1.
- Active arterial disease eg Unstable angina, or recent arterial surgery
- Blood creatine levels above the limits defined in the protocol or +4 proteinuria during dietary lead in period.
- Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Rosuvastatin
|
Other Names:
|
Active Comparator: 2
Simvastatin
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Development of Proteinuria
Time Frame: 2 weekly
|
2 weekly
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Renal effects of rosuvastatin and simvastatin
Time Frame: 2 weekly
|
2 weekly
|
Low density lipoproteins cholesterol levels
Time Frame: 2 weekly
|
2 weekly
|
Safety: adverse events & abnormal laboratory markers
Time Frame: 2 weekly
|
2 weekly
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Russell Esterline, AstraZeneca
- Principal Investigator: Evan Stein, Metabolic & Athersclerotic research centre, Cincinatti, USA
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2002
Study Completion (Actual)
April 1, 2004
Study Registration Dates
First Submitted
April 3, 2008
First Submitted That Met QC Criteria
April 3, 2008
First Posted (Estimate)
April 8, 2008
Study Record Updates
Last Update Posted (Estimate)
March 16, 2009
Last Update Submitted That Met QC Criteria
March 13, 2009
Last Verified
March 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4522IL/0099
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fredrickson Type IIa & Type IIb Dyslipidaemia
-
Chong Kun Dang PharmaceuticalCompletedDyslipidemia (Fredrickson Type Ⅱa) | Dyslipidemia (Fredrickson Type Ⅱb)Korea, Republic of
-
AstraZenecaCompletedType IIa and IIb HypercholesterolaemiaFrance
-
Abramson Cancer Center of the University of PennsylvaniaMassachusetts General HospitalCompleted
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Genzyme, a Sanofi CompanyWithdrawnStage IIB Melanoma | Stage IIC Melanoma | Stage IB Melanoma | Stage IIA MelanomaUnited States
-
Fudan UniversityUnknownStage IA Pancreatic Adenocarcinoma | Stage IB Pancreatic Adenocarcinoma | Stage IIA Pancreatic Adenocarcinoma | Stage IIB Pancreatic AdenocarcinomaChina
-
National Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV Melanoma | Stage IIB Melanoma | Stage IIC Melanoma | Stage IIA MelanomaUnited States
-
National Cancer Institute (NCI)TerminatedProstate Adenocarcinoma | Stage IIA Prostate Cancer AJCC v7 | Stage IIB Prostate Cancer AJCC v7United States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Stage IIB Melanoma | Stage IIC Melanoma | Stage IIA MelanomaUnited States
-
Public Health Foundation of IndiaNational Heart, Lung, and Blood Institute (NHLBI); All India Institute of Medical... and other collaboratorsUnknownHypertension | Type 2 Diabetes Mellitus | DyslipidaemiaIndia, Pakistan
-
University of NebraskaNational Cancer Institute (NCI)TerminatedEsophageal Adenocarcinoma | Adenocarcinoma of the Gastroesophageal Junction | Stage IIB Esophageal Cancer | Stage IIA Esophageal CancerUnited States
Clinical Trials on Rosuvastatin
-
AstraZenecaCompletedDyslipidemia | Kidney DiseaseUnited States, Puerto Rico
-
Yuhan CorporationCompletedHypertension | HyperlipidemiaKorea, Republic of
-
Ottawa Hospital Research InstituteUnknownVenous ThromboembolismCanada, Norway
-
Kobe UniversityCompletedCoronary Artery Disease Progression
-
National Institute of Diabetes and Digestive and...National Institute on Alcohol Abuse and Alcoholism (NIAAA); National Cancer... and other collaboratorsRecruitingCirrhosis | Cirrhosis, Liver | Cirrhosis Due to Hepatitis B | Cirrhosis Due to Hepatitis C | Cirrhosis Early | Cirrhosis Advanced | Cirrhosis Infectious | Cirrhosis Alcoholic | Cirrhosis, Biliary | Cirrhosis Cryptogenic | Cirrhosis Due to Primary Sclerosing CholangitisUnited States
-
Gachon University Gil Medical CenterDaewoong Pharmaceutical Co. LTD.UnknownCoronary Artery DiseaseKorea, Republic of
-
Alvogen KoreaCompletedPrimary HypercholesterolemiaKorea, Republic of
-
Hanmi Pharmaceutical Company LimitedUnknownHealthyKorea, Republic of
-
Organon and CoCompleted