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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00857909
Recruitment Status : Completed
First Posted : March 9, 2009
Last Update Posted : July 8, 2011
Information provided by:
Regional Hospital Holstebro

Brief Summary:
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 or disease Intervention/treatment Phase
High Blood Pressure Drug: Amiloride Drug: Spironolactone Drug: Placebo Drug: Placebo and spironolactone Phase 1

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : January 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Blood pressure [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy
  • Non-smokers

Exclusion Criteria:

  • Smoking
  • Under medical treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00857909

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

Responsible Party: Erling Bjerregaard Pedersen/ Dr. Med, Medical Research Department Identifier: NCT00857909     History of Changes
Other Study ID Numbers: MED.RES:HOS:SKM.02.2009
First Posted: March 9, 2009    Key Record Dates
Last Update Posted: July 8, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents
Acid Sensing Ion Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Epithelial Sodium Channel Blockers