Effect of Pioglitazone on Ambulatory Blood Pressure | NCT00328393

Studies
Effect of Pioglitazone on Ambulatory Blood Pressure

NCT00328393

Sponsor

University of Erlangen-Nürnberg Medical School

Status

Completed

Last Update Posted

Jul 10, 2012Estimated

Enrollment

2Actual

Phase

Phase 3

Conditions

Hypertension
Diabetes Mellitus Type 2

Interventions

Pioglitazone
Placebo

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Mar 2007Actual

Completion Date

Jan 2011Actual

First Submitted Date

May 17, 2006

First Submission Date that Met QC Criteria

May 17, 2006

First Posted Date

May 19, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2012

Last Update Posted Date

Jul 10, 2012Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pioglitazone	Active Comparator	Pioglitazone 45 mg, 8 weeks	Drug: Pioglitazone
Placebo	Placebo Comparator	Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pioglitazone	Drug	45 mg 8 weeks	Pioglitazone
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Median of systolic 24-hour ambulatory blood pressure	Change of 24-hour blood pressure after 8 weeks of treatment	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Median of 24-hour diastolic ambulatory blood pressure	Change of 24-hour diastolic blood pressure after 8 weeks of treatment	8 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roland E Schmieder, Prof.	University of Erlangen-Nürnberg, Medical Department 4	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CRC Medical Department IV		Erlangen		91054	Germany

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077205	Pioglitazone

Ancestor Terms

ID	Term
D045162	Thiazolidinediones
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided