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Effect of Pioglitazone on Ambulatory Blood Pressure

Primary Purpose

Hypertension, Diabetes Mellitus Type 2

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Pioglitazone
Placebo
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • CRC Medical Department IV

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pioglitazone

Placebo

Arm Description

Pioglitazone 45 mg, 8 weeks

Placebo

Outcomes

Primary Outcome Measures

Median of systolic 24-hour ambulatory blood pressure
Change of 24-hour blood pressure after 8 weeks of treatment

Secondary Outcome Measures

Median of 24-hour diastolic ambulatory blood pressure
Change of 24-hour diastolic blood pressure after 8 weeks of treatment

Full Information

First Posted
May 17, 2006
Last Updated
July 6, 2012
Sponsor
University of Erlangen-Nürnberg Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT00328393
Brief Title
Effect of Pioglitazone on Ambulatory Blood Pressure
Official Title
Effect of Pioglitazone on Ambulatory Blood Pressure
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabetes Mellitus Type 2
Keywords
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pioglitazone
Arm Type
Active Comparator
Arm Description
Pioglitazone 45 mg, 8 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Pioglitazone
Intervention Description
45 mg 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Median of systolic 24-hour ambulatory blood pressure
Description
Change of 24-hour blood pressure after 8 weeks of treatment
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Median of 24-hour diastolic ambulatory blood pressure
Description
Change of 24-hour diastolic blood pressure after 8 weeks of treatment
Time Frame
8 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland E Schmieder, Prof.
Organizational Affiliation
University of Erlangen-Nürnberg, Medical Department 4
Official's Role
Principal Investigator
Facility Information:
Facility Name
CRC Medical Department IV
City
Erlangen
ZIP/Postal Code
91054
Country
Germany

12. IPD Sharing Statement

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Effect of Pioglitazone on Ambulatory Blood Pressure

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