NCT00843388

UnknownPhase 4

A Crossover Study With Hexalacton in Patients With Type 1 Di...

Steno Diabetes Center Copenhagen Source

Steno Diabetes Center Copenhagen

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

2306

Secondary identifiers

Eudra CT: 2008-004839-38

Study Type

interventional

Estimated enrollment

20

Locations

0 countries

Sites

N/A

Timeline

Study Start

March 2009

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2010

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

March 2010

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 20 participants
Study completion date: March 2010
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
February 12, 2009
Actual (reported)
First Posted
February 13, 2009
Actual (reported)
Study Start
March 2009
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
March 2010
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2010
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: February 13, 2009
Status Verified: January 2009
Last Update Submitted: February 12, 2009

Conditions

Blood Pressure Diabetes Mellitus Nephropathy

Outcome Measures

Primary Outcomes (1)

albuminuria, expected decrease
60 days

Secondary Outcomes (3)

GFR
60 days
ambulatory blood pressure
60 days
plasma renin, angiotensin, aldosteron
60 days

Study Arms (2)

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

Spironolacton (hexalacton(R))Drug

Tablet Spironolacton 25 mg OD

1

placebo tabletDrug

placebo tablet 25 mg OD

2

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

type 1 diabetes
age 18-80 years

Sponsors & Collaborators

Steno Diabetes Center Copenhagen
Otherlead

MeSH Terms

Conditions

Diabetes MellitusKidney Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

stine e nielsen, MD
Steno Diabetes Center Copenhagen
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: OTHER

Study Record Dates

First Submitted

February 12, 2009

First Posted

February 13, 2009

Study Start

March 2009

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2010

Estimated (date passed)

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Phase 4Unknown

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microalbuminuria

You may not qualify if:

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

Contact the study team to confirm eligibility.

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

March 2010

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

February 13, 2009

Record last verified: 2009-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00843388
Data provider: ClinicalTrials.gov
Source updated: 2009-02-13
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:34:26 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record