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The Effect of Spironolactone on Blood Pressure in Type-2 Diabetics With Resistant Hypertension (SDHDS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01062763
First Posted: February 4, 2010
Last Update Posted: May 8, 2014
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.
Information provided by (Responsible Party):
Ib Abildgaard Jacobsen, Odense University Hospital
February 3, 2010
February 4, 2010
June 27, 2013
May 8, 2014
May 8, 2014
March 2010
March 2012   (Final data collection date for primary outcome measure)
  • Change of of Systolic Blood Pressure [ Time Frame: 4 months ]
    Change of systolic blood pressure from baseline to study end at four months.
  • Change of Diastolic Blood Pressure [ Time Frame: 4 months ]
    Change of diastolic blood pressure from baseline to study end at four months.
Blood pressure reduction [ Time Frame: 4 months ]
Complete list of historical versions of study NCT01062763 on ClinicalTrials.gov Archive Site
Adverse Effects [ Time Frame: 4 months ]
Same as current
Not Provided
Not Provided
 
The Effect of Spironolactone on Blood Pressure in Type-2 Diabetics With Resistant Hypertension
South Danish Hypertension and Diabetes Study
The purpose of this study is to estimate the effect of spironolactone on blood pressure resistant to therapy in type-2 diabetics.

The primary object of the study is to estimate the effect of addition of low dose spironolactone to antihypertensive treatment with at least three antihypertensive drugs in patients with type-2 diabetes and blood pressure over 130/80 mmHg.

Secondary aims are to estimate how many of these patients have their blood pressure controlled by the addition of spironolactone, to investigate whether the addition of spironolactone affects insulin sensitivity and urinary protein secretion and to estimate the incidence of adverse effects of the aldosterone antagonist.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Arterial Hypertension
  • Hypertension, Resistant to Conventional Therapy
  • Diabetes Mellitus
  • Drug: spironolactone
    25 to 50 mg once daily
  • Drug: placebo
    addition of placebo 1 to 2 tablets daily
  • Experimental: addition of spironolactone
    spironolactone is added to previous antihypertensive treatment
    Intervention: Drug: spironolactone
  • Placebo Comparator: Placebo
    Addition of placebo
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
119
May 2012
March 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age < 75 years
  • Type-2 diabetes
  • Therapy resistant hypertension (by ABPM)
  • Treatment with at least 3 antihypertensives

Exclusion Criteria:

  • HbA1c > 10.0
  • BP > 180/110 mmHg
  • Secondary hypertension
  • Intolerance to spironolactone
  • Permanent treatment with nonsteroidal antiinflammatory drugs or systemic glucocorticoids
  • Total cholesterol 10 mmol/l
  • New York Heart Association class III and IV
  • Pregnancy or planned pregnancy
  • Psychiatric disease
  • Malignant disease
  • Insufficient adherence
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Denmark
 
NCT01062763
EudraCT 2009-017033-22
2009-017033-22 ( EudraCT Number )
No
Not Provided
Not Provided
Ib Abildgaard Jacobsen, Odense University Hospital
Ib Abildgaard Jacobsen
Not Provided
Principal Investigator: Ib A Jacobsen, DMSc Odense University Hospital
Odense University Hospital
April 2014

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