Phase 3
N=119
The Effect of Spironolactone on Blood Pressure in Type-2 Diabetics With Resistant Hypertension
Arterial Hypertension · Hypertension, Resistant to Conventional Therapy · Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT01062763 ↗Enrolled (actual)
119
Serious AEs
0.8%
Results posted
May 2014
Primary outcome: Primary: Change of of Systolic Blood Pressure — -9.6; -0.7 mm Hg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- spironolactone (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ib Abildgaard Jacobsen
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of of Systolic Blood Pressure |
-9.6; -0.7 | — |
| PRIMARY Change of Diastolic Blood Pressure |
-3.9; -0.3 | — |
| SECONDARY Adverse Effects |
4; 0 | — |
Summary
The purpose of this study is to estimate the effect of spironolactone on blood pressure resistant to therapy in type-2 diabetics.
Eligibility Criteria
Inclusion Criteria
- Age 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
Data sourced from ClinicalTrials.gov (NCT01062763). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.