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Effect of Pioglitazone on Ambulatory Blood Pressure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00328393
First Posted: May 19, 2006
Last Update Posted: July 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School
May 17, 2006
May 19, 2006
July 10, 2012
March 2007
March 2007   (Final data collection date for primary outcome measure)
Median of systolic 24-hour ambulatory blood pressure [ Time Frame: 8 weeks ]
Change of 24-hour blood pressure after 8 weeks of treatment
Not Provided
Complete list of historical versions of study NCT00328393 on ClinicalTrials.gov Archive Site
Median of 24-hour diastolic ambulatory blood pressure [ Time Frame: 8 weeks ]
Change of 24-hour diastolic blood pressure after 8 weeks of treatment
Not Provided
Not Provided
Not Provided
 
Effect of Pioglitazone on Ambulatory Blood Pressure
Effect of Pioglitazone on Ambulatory Blood Pressure
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Hypertension
  • Diabetes Mellitus Type 2
  • Drug: Pioglitazone
    45 mg 8 weeks
  • Drug: Placebo
    Placebo
  • Active Comparator: Pioglitazone
    Pioglitazone 45 mg, 8 weeks
    Intervention: Drug: Pioglitazone
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2
January 2011
March 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00328393
2005-000570-52
Not Provided
Not Provided
Not Provided
University of Erlangen-Nürnberg Medical School
University of Erlangen-Nürnberg Medical School
Not Provided
Principal Investigator: Roland E Schmieder, Prof. University of Erlangen-Nürnberg, Medical Department 4
University of Erlangen-Nürnberg Medical School
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP