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OpenTrials
Completed

NCT Number: NCT00328393

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus Type 2 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

CRC Medical Department IV

Erlangen, 91054, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pioglitazone

Drug

45 mg 8 weeks

Placebo

Drug

Placebo

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2011
First posted
May 19, 2006
Registry last updated
Jul 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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