Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Effects of Amiloride and Spironolactone on Renophysiological and Cardiovascular Variables (hass)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Erling Bjerregaard Pedersen, Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT01195805
First received: September 3, 2010
Last updated: March 1, 2014
Last verified: March 2014

September 3, 2010
March 1, 2014
August 2010
March 2014   (final data collection date for primary outcome measure)
Bloodpressure [ Time Frame: 24-hours and examination ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01195805 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Effects of Amiloride and Spironolactone on Renophysiological and Cardiovascular Variables
The Effect of Amiloride and Spironolactone on Renovascular and Cardiovascular Variables in Patients With Essential Hypertension in a Doubleblinded, Randomized, Placebo-controlled, Crossover Study.

The investigators wish to study the effect of retaining potassium. The participants have essential hypertension. The test substances are Amiloride, Spironolactone and placebo. The participants will ingest tablets for 28 days before being examined. We will perform a 24 hours urine collection, 24-hours bloodpressure measurement, blood and urine samples and we also examine the patient using a SphygmoCor.

Purpose of the study is to examine the effect of amiloride and spironolactone on

  1. Renal function (GFR, u-AQP2, u-ENaCβ, u-cAMP, u-PGE2, CH20, FENa, FEK),
  2. Pulsewave velocity, augmentation index central bloodpressure,
  3. Vasoactive hormones (PRC, AngII, Aldo, AVP, ANP, BNP and Endot), and
  4. Ambulatory bloodpressure
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Essential Hypertension
  • Drug: Spironolactone
    1 tablet twice a day for 28 days
  • Other: Placebo
    1 tablet twice a day for 28 days
  • Drug: Amiloride
    1 tablet twice a day for 28 days
  • Active Comparator: Amiloride
    Intervention: Drug: Amiloride
  • Active Comparator: Spironolactone
    Intervention: Drug: Spironolactone
  • Placebo Comparator: Placebo
    1 tablet twice a day for 28 days
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • hypertension,
  • BMI 18,5-30,
  • non-smoker

Exclusion Criteria:

  • Smoking
  • Not using contraceptives
  • Other illnesses
  • Drug or alcohol abuse
Both
40 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01195805
MED.RES.HOS.2010.03.SKM
Yes
Erling Bjerregaard Pedersen, Regional Hospital Holstebro
Regional Hospital Holstebro
Not Provided
Principal Investigator: Solveig K Matthesen, MD Departments of medical research and medicine
Regional Hospital Holstebro
March 2014

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