NCT00328393

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_3 hypertension

Timeline
Completed

Started Mar 2007

Longer than P75 for phase_3 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2006

Completed
10 months until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

July 10, 2012

Status Verified

July 1, 2012

Enrollment Period

Same day

First QC Date

May 17, 2006

Last Update Submit

July 6, 2012

Conditions

HypertensionDiabetes Mellitus Type 2

Keywords

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Median of systolic 24-hour ambulatory blood pressure

    Change of 24-hour blood pressure after 8 weeks of treatment

    8 weeks

Secondary Outcomes (1)

  • Median of 24-hour diastolic ambulatory blood pressure

    8 weeks

Study Arms (2)

Pioglitazone

ACTIVE COMPARATOR

Pioglitazone 45 mg, 8 weeks

Drug: Pioglitazone

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

PioglitazoneDRUG

45 mg 8 weeks

Pioglitazone
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 45-75 years
  • Diabetes mellitus Type 2 (HbA1c 7 - 8.5%)
  • Casual blood pressure \> = 130/80 mmHg, \< 160/100 mmHg

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRC Medical Department IV

Erlangen, 91054, Germany

Location

MeSH Terms

Conditions

HypertensionDiabetes Mellitus, Type 2

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Roland E Schmieder, Prof.

    University of Erlangen-Nürnberg, Medical Department 4

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2006

First Posted

May 19, 2006

Study Start

March 1, 2007

Primary Completion

March 1, 2007

Study Completion

January 1, 2011

Last Updated

July 10, 2012

Record last verified: 2012-07

Locations

DE(1)