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Effect of Pioglitazone on Ambulatory Blood Pressure

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ClinicalTrials.gov Identifier: NCT00328393
Recruitment Status : Completed
First Posted : May 19, 2006
Last Update Posted : July 10, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypertension Diabetes Mellitus Type 2 Drug: Pioglitazone Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Pioglitazone on Ambulatory Blood Pressure
Study Start Date : March 2007
Actual Primary Completion Date : March 2007
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Pioglitazone
Pioglitazone 45 mg, 8 weeks
Drug: Pioglitazone
45 mg 8 weeks
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo



Primary Outcome Measures :
  1. Median of systolic 24-hour ambulatory blood pressure [ Time Frame: 8 weeks ]
    Change of 24-hour blood pressure after 8 weeks of treatment


Secondary Outcome Measures :
  1. Median of 24-hour diastolic ambulatory blood pressure [ Time Frame: 8 weeks ]
    Change of 24-hour diastolic blood pressure after 8 weeks of treatment



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT00328393     History of Changes
Other Study ID Numbers: 2005-000570-52
First Posted: May 19, 2006    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: July 2012

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

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