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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ib Abildgaard Jacobsen, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01062763
First received: February 3, 2010
Last updated: April 8, 2014
Last verified: April 2014
Results First Received: June 27, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Arterial Hypertension
Hypertension, Resistant to Conventional Therapy
Diabetes Mellitus
Interventions: Drug: spironolactone
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients recruited from outpatient clinics of endocrinology at two university hospitals and two general hospitals in the period from May 2010 to March 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
163 patints screened. 44 screenfailures due to exclusion criteria as indicated. 119 randomized

Reporting Groups
  Description
Placebo 1tablet of matching placebo trated up to 2 if neccessary
Addition of Spironolactone

spironolactone is added to previous antihypertensive treatment

placebo : addition of placebo 1 to 2 tablets daily

spironolactone : 25 to 50 mg once daily


Participant Flow:   Overall Study
    Placebo     Addition of Spironolactone  
STARTED     58 [1]   61  
COMPLETED     55     57  
NOT COMPLETED     3     4  
Adverse Event                 3                 4  
[1] 119 randomized.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Addition of Spironolactone

spironolactone is added to previous antihypertensive treatment

placebo : addition of placebo 1 to 2 tablets daily

spironolactone : 25 to 50 mg once daily

Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
    Addition of Spironolactone     Placebo     Total  
Number of Participants  
[units: participants]
  61     58     119  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     34     28     62  
>=65 years     27     30     57  
Age  
[units: years]
Mean ± Standard Deviation
  62.9  ± 7.1     63.9  ± 6.9     63.4  ± 6.9  
Gender  
[units: participants]
     
Female     15     13     28  
Male     46     45     91  
Region of Enrollment  
[units: participants]
     
Denmark     61     58     119  



  Outcome Measures
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1.  Primary:   Change of of Systolic Blood Pressure   [ Time Frame: 4 months ]

2.  Primary:   Change of Diastolic Blood Pressure   [ Time Frame: 4 months ]

3.  Secondary:   Adverse Effects   [ Time Frame: 4 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Ib A. Jacobsen
Organization: Dept. of Endocrinology, Odense University Hospital
phone: +45 27203135
e-mail: ib.abildgaard@rsyd.dk


Publications:

Responsible Party: Ib Abildgaard Jacobsen, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01062763     History of Changes
Other Study ID Numbers: EudraCT 2009-017033-22, 2009-017033-22
Study First Received: February 3, 2010
Results First Received: June 27, 2013
Last Updated: April 8, 2014
Health Authority: Denmark: Danish Medicines Agency