Effect of Pioglitazone on Ambulatory Blood Pressure

University of Erlangen-Nürnberg Medical School

Status and phase: Completed; Phase 3

Conditions: Hypertension; Diabetes Mellitus Type 2

Treatments: Drug: Placebo; Drug: Pioglitazone

Study type: Interventional

Funder types: Other

Identifiers

NCT00328393

2005-000570-52

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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2 participants in 2 patient groups, including a placebo group

Pioglitazone

Active Comparator group

Description:

Pioglitazone 45 mg, 8 weeks

Treatment:

Drug: Pioglitazone

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo