Status:
COMPLETED
Effect of Pioglitazone on Ambulatory Blood Pressure
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Conditions:
Hypertension
Diabetes Mellitus Type 2
Eligibility:
MALE
18-75 years
Phase:
PHASE3
Brief Summary
The anti-diabetic pioglitazone has been found to reduce casual blood pressure. To date, no data are available looking at this effect in detail. Especially, ambulatory blood pressure has not yet been u...
Eligibility Criteria
Inclusion
- Age 45-75 years
- Diabetes mellitus Type 2 (HbA1c 7 - 8.5%)
- Casual blood pressure \> = 130/80 mmHg, \< 160/100 mmHg
Exclusion
- Therapy with insulin
- Combination therapy of sulfonyl-urea und metformin
- Therapy with nateglinid, repaglinid or an other substance of this drug family
- Allergy against pioglitazone or other composites of the tablet
- History of heart failure (NYHA I bis IV)
- Hepatic insufficiency
- Transaminases \> 2.5-fold of the upper normal limit
- End-stage renal failure
- Syndrome of polycystic ovaries
- Absence of effective contraception in women of childbearing potential
- Pregnancy or breast-feeding
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00328393
Start Date
March 1 2007
End Date
January 1 2011
Last Update
July 10 2012
Active Locations (1)
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1
CRC Medical Department IV
Erlangen, Germany, 91054