Overview

Effect of Pioglitazone on Ambulatory Blood Pressure

Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Treatments:
Pioglitazone
Criteria
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