A Crossover Study With Hexalacton in Patients With Type 1... | NCT00843388

Studies
A Crossover Study With Hexalacton in Patients With Type 1 Diabetes and Microalbuminuria

NCT00843388

Sponsor

Steno Diabetes Center Copenhagen

Status

Unknown status

Last Update Posted

Feb 13, 2009Estimated

Enrollment

20Estimated

Phase

Phase 4

Conditions

Diabetes Mellitus
Nephropathy
Blood Pressure

Interventions

Spironolacton (hexalacton(R))
placebo tablet

Countries

Not provided

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Eudra CT: 2008-004839-38

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Mar 2010Estimated

Completion Date

Mar 2010Estimated

First Submitted Date

Feb 12, 2009

First Submission Date that Met QC Criteria

Feb 12, 2009

First Posted Date

Feb 13, 2009Estimated

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

Feb 12, 2009

Last Update Posted Date

Feb 13, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A double blind, randomized, cross over study in type 1 diabetic patients. 20 patients, age 18-65 years is treated with spironolacton (Hexalacton (R)) for 60 days followed by 60 days treatment with placebo(or opposite). Primary aim: albuminuria, an expected decrease during hexalacton treatment. Secondary aim: ambulatory blood pressure, GFR, plasma-renin, angiotensin, aldosteron.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	60 days treatment with tablet hexalacton 25 mg OD.	Drug: Spironolacton (hexalacton(R))
2	Placebo Comparator	Inactive drug of 25 mg OD	Drug: placebo tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Spironolacton (hexalacton(R))	Drug	Tablet Spironolacton 25 mg OD	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
albuminuria, expected decrease		60 days

Secondary Outcomes

Measure	Description	Time Frame
GFR		60 days
ambulatory blood pressure		60 days
plasma renin, angiotensin, aldosteron

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

type 1 diabetes
age 18-80 years
microalbuminuria

Exclusion Criteria:

blood pressure> 160/100 mmHg
persistent macroalbuminuria
pregnancy or in risc of this
P-Potassium>5.7 mmol/l
Eplerone treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 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
stine e nielsen, MD	Steno Diabetes Center Copenhagen	Principal Investigator

Locations

Not provided

Unposted Events

Type	Date	Date Unknown
Release	Sep 2, 2012
Reset	Oct 2, 2012
Release	Oct 31, 2012
Reset	Nov 27, 2012
Release	Dec 19, 2012
Reset	Jan 29, 2013
Release	Jul 5, 2013
Reset	Aug 6, 2013
Release	Jan 30, 2015
Reset	Feb 18, 2015
Release	Jul 7, 2015
Reset	Jul 15, 2015

Submission Tracking

Estimated Results First Submitted Date

Sep 2, 2012

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Sep 2, 2012			Oct 2, 2012
Oct 31, 2012

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D007674	Kidney Diseases

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided