The Effect of Amiloride and Spironolactone in Healthy Persons - Full Text View

Sponsor:	Holstebro Hospital
Information provided by:	Holstebro Hospital
ClinicalTrials.gov Identifier:	NCT00857909

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 I

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:

MedlinePlus related topics: High Blood Pressure Potassium

Drug Information available for: Spironolactone Amiloride

U.S. FDA Resources

Further study details as provided by Holstebro Hospital:

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:

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

Holstebro Hospital

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 February 09, 2012