Effect of Pioglitazone on Ambulatory Blood Pressure

Hypertension Clinical Trial

Official title:

Effect of Pioglitazone on Ambulatory Blood Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00328393
• Other study ID #: 2005-000570-52
• Status: Completed
• Phase: Phase 3
• First received: May 17, 2006
• Last updated: July 6, 2012
• Start date: March 2007
• Est. completion date: January 2011

Study information

• Verified date: July 2012
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: January 2011
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• Hypertension

Intervention

Drug:
• Pioglitazone
45 mg 8 weeks
• Placebo
Placebo

Locations

Country	Name	City	State
Germany	CRC Medical Department IV	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median of systolic 24-hour ambulatory blood pressure	Change of 24-hour blood pressure after 8 weeks of treatment	8 weeks	No
Secondary	Median of 24-hour diastolic ambulatory blood pressure	Change of 24-hour diastolic blood pressure after 8 weeks of treatment	8 weeks	No