Effect of Pioglitazone on Ambulatory Blood Pressure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT00328393
First received: May 17, 2006
Last updated: July 6, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Hypertension
Diabetes Mellitus Type 2
Drug: Pioglitazone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Pioglitazone on Ambulatory Blood Pressure

Resource links provided by NLM:


Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • Median of systolic 24-hour ambulatory blood pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Change of 24-hour blood pressure after 8 weeks of treatment


Secondary Outcome Measures:
  • Median of 24-hour diastolic ambulatory blood pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Change of 24-hour diastolic blood pressure after 8 weeks of treatment


Enrollment: 2
Study Start Date: March 2007
Study Completion Date: January 2011
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pioglitazone
Pioglitazone 45 mg, 8 weeks
Drug: Pioglitazone
45 mg 8 weeks
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00328393

Locations
Germany
CRC Medical Department IV
Erlangen, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
Principal Investigator: Roland E Schmieder, Prof. University of Erlangen-Nürnberg, Medical Department 4
  More Information

No publications provided

Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT00328393     History of Changes
Other Study ID Numbers: 2005-000570-52
Study First Received: May 17, 2006
Last Updated: July 6, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Erlangen-Nürnberg Medical School:
Hypertension

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014