Effectiveness of Eplerenone to Improve Target Organ Damage in Patients With Resistant Arterial Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roland E. Schmieder, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT00138944
First received: August 29, 2005
Last updated: April 16, 2013
Last verified: April 2013

August 29, 2005
April 16, 2013
January 2007
May 2008   (final data collection date for primary outcome measure)
Change of left ventricular mass [ Time Frame: 3 months vs. baseline ] [ Designated as safety issue: No ]
MRT assessment of left ventricular mass
Not Provided
Complete list of historical versions of study NCT00138944 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effectiveness of Eplerenone to Improve Target Organ Damage in Patients With Resistant Arterial Hypertension
Effectiveness of Eplerenone to Improve Target Organ Damage in Patients With Resistant Arterial Hypertension

Resistant hypertension is defined as hypertension not controlled (i.e. blood pressure not below 140/90 mmHg) with the use of adequate doses of at least three different anti-hypertensives including a diuretic. Resistant hypertension is abundant. In the ALLHAT trial 34% of patients did not reach the blood pressure goal of 140/90 mmHg. One possible mechanism of resistance is the aldosterone-escape phenomenon.

During aldosterone escape, aldosterone plasma levels are normal or even elevated despite therapy with ACEIs or ARBs. The prevalence is about 30-50%. Possible reasons for aldosterone escape are alternative ways of aldosterone stimulation (hyperkalemia, adrenomedullin, ACTH), local aldosterone production or primary aldosteronism. Aldosterone has deleterious blood pressure independent effects on cardiac, vascular and renal damage.

Hypothesis: Eplerenone is effective to improve hypertensive target organ damage in patients with resistant hypertension.

see above

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Essential Hypertension
  • Drug: placebo
    od
  • Drug: eplerenone
    50mg od
  • Placebo Comparator: 1
    Placebo
    Intervention: Drug: placebo
  • Active Comparator: 2
    Eplerenone
    Intervention: Drug: eplerenone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
85
July 2008
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Casual blood pressure >=140/90 despite effective triple therapy including an ACEI/ARB and a diuretic

Exclusion Criteria:

  • Contraindication for eplerenone
  • Creatinine-Clearance < 60 ml/min
  • Diabetes mellitus
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00138944
KFO_TP5/2, DFG KFO 106-2 TP5
No
Roland E. Schmieder, University of Erlangen-Nürnberg Medical School
University of Erlangen-Nürnberg Medical School
Not Provided
Study Chair: Roland E Schmieder, MD University Erlangen-Nuremberg
University of Erlangen-Nürnberg Medical School
April 2013

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