Text Size

The Effect of Amiloride and Spironolactone in Healthy Persons (SPAS)

This study has been completed.
Sponsor:
Information provided by:
Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT00857909
First received: March 6, 2009
Last updated: July 7, 2011
Last verified: July 2011
History of Changes
  Purpose

This study will investigate whether retaining potassium in the body will lead to changes in blood pressure and changes in blood and urine samples.


Condition Intervention Phase
High Blood Pressure
 Drug: Amiloride
Drug: Spironolactone
Drug: Placebo
Drug: Placebo and spironolactone
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Amiloride and Spironolactone Measured on Cardiovascular and Kidney Related Variables in Healthy Subjects in a Double-blinded, Randomised, Placebo-controlled, Cross-over Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Regional Hospital Holstebro:

Primary Outcome Measures:
  • Blood pressure [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: January 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Randomisation 1
Amiloride 5 mg twice daily for 28 days, later compared with spironolactone and placebo
 Drug: Amiloride
1 tablet twice a day
Drug: Placebo and spironolactone
5mg twice daily
Active Comparator: Randomisation 2
Spironolactone 25 mg twice daily, to be compared with placebo and amiloride
 Drug: Spironolactone
1 tablet twice a day
Drug: Spironolactone
25mg twice daily
Placebo Comparator: Placebo
calcium tablet
 Drug: Placebo
Placebo

Detailed Description:

The purpose is to measure the effect of amiloride and spironolactone on:

  1. Renal function (GFR, u-AQP2, u-ENaCβ, u-cAMP, u-PGE2, CH20, FENa, FEK),
  2. Pulsbewave velocity, augmentation index and central blood pressure,
  3. Vasoactive hormones (PRC, AngII, Aldo, AVP, ANP, BNP and Endot), and
  4. Ambulatory blood pressure
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • Non-smokers

Exclusion Criteria:

  • Smoking
  • Under medical treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00857909

Locations
Denmark
Medical Research
Holstebro, Denmark, 7500
Sponsors and Collaborators
Regional Hospital Holstebro
Investigators
Principal Investigator: Erling B Pedersen, Prof Regional Hospital Holstebro
  More Information

No publications provided

Responsible Party: Erling Bjerregaard Pedersen/ Dr. Med, Medical Research Department
ClinicalTrials.gov Identifier: NCT00857909     History of Changes
Other Study ID Numbers: MED.RES:HOS:SKM.02.2009
Study First Received: March 6, 2009
Last Updated: July 7, 2011
Health Authority: Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amiloride
Spironolactone
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Cardiovascular Agents
Therapeutic Uses
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 16, 2013