Effect of Pioglitazone on Ambulatory Blood Pressure
Phase 3
Completed
- Conditions
- Diabetes Mellitus Type 2Hypertension
- Interventions
- Drug: Placebo
- Registration Number
- NCT00328393
- Lead Sponsor
- University of Erlangen-Nürnberg Medical School
- 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 utilized to confirm the hypothesis that pioglitazone has blood pressure lowering effects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 2
Inclusion Criteria
- Age 45-75 years
- Diabetes mellitus Type 2 (HbA1c 7 - 8.5%)
- Casual blood pressure > = 130/80 mmHg, < 160/100 mmHg
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo Pioglitazone Pioglitazone Pioglitazone 45 mg, 8 weeks
- Primary Outcome Measures
Name Time Method Median of systolic 24-hour ambulatory blood pressure 8 weeks Change of 24-hour blood pressure after 8 weeks of treatment
- Secondary Outcome Measures
Name Time Method Median of 24-hour diastolic ambulatory blood pressure 8 weeks Change of 24-hour diastolic blood pressure after 8 weeks of treatment
Trial Locations
- Locations (1)
CRC Medical Department IV
🇩🇪Erlangen, Germany