NCT00770497

Brief Summary

The purpose of this study is to determine the effects of pioglitazone, once daily (QD), on low grade inflammation and vascular function in hypertensive patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
172

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

13 active sites

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

Study Start

First participant enrolled

March 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2008

Completed
Last Updated

July 5, 2010

Status Verified

July 1, 2010

Enrollment Period

1.2 years

First QC Date

October 9, 2008

Last Update Submit

July 1, 2010

Conditions

InflammationHypertension

Keywords

drug effectsHypertensionVascular ResistanceDrug Therapyphysiopathology, vascular

Outcome Measures

Primary Outcomes (1)

  • Change in the high-sensitivity C-reactive Protein value.

    Week: 12.

Secondary Outcomes (28)

  • Change from Baseline in Glucose tolerance as assessed by an oral glucose tolerance test.

    Week: 12.

  • Change from Baseline in Insulin sensitivity according to the Homeostatic Model Assessment - Sensitivity score and Insulin Secretion.

    Weeks: 6 and 12.

  • Change from Baseline in Glycosylated Hemoglobin levels.

    Week: 12.

  • Change from Baseline in C-Peptide levels.

    Weeks: 6 and 12.

  • Change from Baseline in Proinsulin intact levels.

    Weeks: 6 and 12.

  • +23 more secondary outcomes

Study Arms (3)

Pioglitazone 15 mg to 30 mg QD

EXPERIMENTAL
Drug: Pioglitazone

Pioglitazone 15 mg to 30 mg QD + Ramipril 2.5 mg to 5 mg QD

ACTIVE COMPARATOR
Drug: Pioglitazone and ramipril

Ramipril 2.5 mg to 5 mg QD

ACTIVE COMPARATOR
Drug: Ramipril

Interventions

PioglitazoneDRUG

Pioglitazone 15 mg, tablets, orally, once daily and ramipril placebo-matching tablets, orally, once daily for two weeks; increased to: Pioglitazone 30 mg, tablets, orally, once daily and ramipril placebo-matching tablets, orally, once daily for up to 10 weeks.

Also known as: ACTOS®, AD4833
Pioglitazone 15 mg to 30 mg QD
Pioglitazone and ramiprilDRUG

Pioglitazone 15 mg, tablets, orally, once daily and ramipril 2.5 mg, tablets, orally, once daily for two weeks; increased to: Pioglitazone 30 mg, tablets, orally, once daily and ramipril 5 mg, tablets, orally, once daily for up to 10 weeks.

Also known as: ACTOS®, AD4833
Pioglitazone 15 mg to 30 mg QD + Ramipril 2.5 mg to 5 mg QD
RamiprilDRUG

Pioglitazone placebo-matching tablets, orally, once daily and ramipril 2.5 mg, tablets, orally, once daily for two weeks; increased to: Pioglitazone placebo-matching tablets, orally, once daily and ramipril 5 mg, tablets, orally, once daily for up to 10 weeks.

Ramipril 2.5 mg to 5 mg QD

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has arterial hypertension.
  • Is on stable treatment with an Angiotensin Converting Enzyme inhibitor at least for 12 weeks.
  • Has a high sensitive C-Reactive Protein value greater than 1.0 mg/L and less than 10.0 mg/L.
  • Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.

You may not qualify if:

  • Manifests or has newly detected diabetes mellitus type 2 according to World Health Organization criteria.
  • Has Type 1 Diabetes.
  • Has acute infections.
  • Chronic inflammatory diseases which cause elevated CRP-values (e.g. rheumatic diseases, pyelonephritis or osteomyelitis).
  • Use of acetyl salicylic acid and/or Non-steroidal Anti-inflammatory Drugs or Cox-2-inhibitors within the last 4 weeks prior to screening visit, use of Rifampicin within the last 12 weeks prior to screening visit.
  • Uncontrolled hypertension (repeated blood pressure greater than 180/100 mmHg for at least three times within two weeks); persistent hypotension (systolic less than 90 mmHg) or hemodynamic instability.
  • Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures.
  • History of severe or multiple allergies.
  • Treatment with any other investigational drug within 3 months before trial entry.
  • Has a progressive, fatal disease.
  • History of drug or alcohol abuse within the last 5 years.
  • A history of significant cardiovascular (New York Heart Association stage I - IV, hemodynamic relevant aortic or mitral valve stenosis, hypertrophic obstructive cardiomyopathy), respiratory, gastrointestinal, hepatic (alanine aminotransferase greater than 2.5 times the normal reference range), renal (creatinine greater than 2.0 mg/dL), or hematological disease, history of macular edema.
  • State after kidney transplantation, hemodynamic relevant renal artery stenosis (bilateral or unilateral in case of single kidney).
  • Blood donation within the last 30 days.
  • Serum potassium greater than 5.5 mmol/L.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Unknown Facility

Deggingen, Baden-Wurttemberg, Germany

Location

Unknown Facility

Rottweil, Baden-Wurttemberg, Germany

Location

Unknown Facility

Spaichingen, Baden-Wurttemberg, Germany

Location

Unknown Facility

Weilersbach, Bavaria, Germany

Location

Unknown Facility

Hanover, Lower Saxony, Germany

Location

Unknown Facility

Cologne, North Rhine-Westphalia, Germany

Location

Unknown Facility

Essen, North Rhine-Westphalia, Germany

Location

Unknown Facility

Werne, North Rhine-Westphalia, Germany

Location

Unknown Facility

Mainz, Rhineland-Palatinate, Germany

Location

Unknown Facility

Schauenburg, Rhineland-Palatinate, Germany

Location

Unknown Facility

Dresden, Saxony, Germany

Location

Unknown Facility

Berlin, State of Berlin, Germany

Location

Unknown Facility

Blankenhain, Thuringia, Germany

Location

Related Links

MeSH Terms

Conditions

InflammationHypertension

Interventions

PioglitazoneRamipril

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Medical Adviser Clinical Research

    Takeda Pharma Gmbh, Aachen (Germany)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 9, 2008

First Posted

October 10, 2008

Study Start

March 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

July 5, 2010

Record last verified: 2010-07

Locations

DE(13)