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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00843388
Recruitment Status : Unknown
Verified January 2009 by Steno Diabetes Center Copenhagen.
Recruitment status was:  Not yet recruiting
First Posted : February 13, 2009
Last Update Posted : February 13, 2009
Sponsor:
Information provided by:
Steno Diabetes Center Copenhagen

Tracking Information
First Submitted Date  ICMJE February 12, 2009
First Posted Date  ICMJE February 13, 2009
Last Update Posted Date February 13, 2009
Study Start Date  ICMJE March 2009
Estimated Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2009)
albuminuria, expected decrease [ Time Frame: 60 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2009)
  • GFR [ Time Frame: 60 days ]
  • ambulatory blood pressure [ Time Frame: 60 days ]
  • plasma renin, angiotensin, aldosteron [ Time Frame: 60 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Crossover Study With Hexalacton in Patients With Type 1 Diabetes and Microalbuminuria
Official Title  ICMJE A Randomized Doubleblind Placebo Controlled Crossover Study With Hexalacton in Patients With Type 1 Diabetes and Microalbuminuria
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus
  • Nephropathy
  • Blood Pressure
Intervention  ICMJE
  • Drug: Spironolacton (hexalacton(R))
    Tablet Spironolacton 25 mg OD
  • Drug: placebo tablet
    placebo tablet 25 mg OD
Study Arms  ICMJE
  • Active Comparator: 1
    60 days treatment with tablet hexalacton 25 mg OD.
    Intervention: Drug: Spironolacton (hexalacton(R))
  • Placebo Comparator: 2
    Inactive drug of 25 mg OD
    Intervention: Drug: placebo tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 12, 2009)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2010
Estimated Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00843388
Other Study ID Numbers  ICMJE 2306
Eudra CT: 2008-004839-38
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peter Rossing, Steno Diabetes Center, Dep 520
Study Sponsor  ICMJE Steno Diabetes Center Copenhagen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: stine e nielsen, MD Steno Diabetes Center Copenhagen
PRS Account Steno Diabetes Center Copenhagen
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP