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Note: This record shows only 24 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00151710
Date of registration: 08/09/2005
Prospective Registration: No
Primary sponsor: Radboud University
Public title: Effects of Pioglitazone in Congenital Adrenal Hyperplasia
Scientific title: Effects of Pioglitazone in Glucocorticoid-Induced Insulin Resistance. Studies in Congenital Adrenal Hyperplasia.
Date of first enrolment: May 2005
Target sample size:
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00151710
Study type:  Interventional
Study design:  Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind  
Phase:  N/A
Countries of recruitment
Netherlands
Contacts
Contact type:
Name:     Cornelis J Tack, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Radboud University
Key inclusion & exclusion criteria

Inclusion Criteria:

- biochemical and genetically proven congenital adrenal hyperplasia

- stable corticosteroid replacement for 3 months

Exclusion Criteria:

- age < 18 years

- inability to give informed consent

- significant cardiovascular disease, defined as myocardial infarction or stroke, six
months preceding the study

- significant renal disease, GFR < 30 ml/min

- significant liver disease, defined as more than 3 times upper limit of normal values
of alanine aminotransferase (ALT) and aspartate aminotransferase (AST)

- pregnancy

- mental disease



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Congenital Adrenal Hyperplasia
Intervention(s)
Drug: Pioglitazone
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
H6E-UT-O013
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
URL:
URL of the protocol:
Date Posted:
Date of completion:
Date of first publication:
Results summary:
Baseline characteristics:
Adverse events:
Outcome measures:
IPD sharing plan:
IPD sharing description:
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