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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Odense University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Ib Abildgaard Jacobsen, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01062763
First received: February 3, 2010
Last updated: December 7, 2011
Last verified: December 2011

February 3, 2010
December 7, 2011
March 2010
March 2012   (final data collection date for primary outcome measure)
Blood pressure reduction [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01062763 on ClinicalTrials.gov Archive Site
Adverse effects [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Arterial Hypertension
  • Resistant Hypertension
  • Diabetes Mellitus
  • Aldosterone Antagonism
  • Drug: spironolactone
    25 to 50 mg once daily
    Other Name: Spirix
  • Drug: placebo
    addition of placebo 1 to 2 tablets daily
Experimental: addition of spironolactone
spironolactone is added to previous antihypertensive treatment
Interventions:
  • Drug: spironolactone
  • Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
135
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 NSAID or systemic glucocorticoids
  • Total cholesterol 10 mmol/l
  • NYHA class III and IV
  • Pregnancy or planned pregnancy
  • Psychiatric disease
  • Malignant disease
  • Insufficient adherence
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01062763
EudraCT 2009-017033-22, 2009-017033-22
No
Ib Abildgaard Jacobsen, Odense University Hospital
Ib Abildgaard Jacobsen
Not Provided
Principal Investigator: Ib A Jacobsen, DMSc Odense University Hospital
Odense University Hospital
December 2011

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