SPAS: The Effect of Amiloride and Spironolactone in Healthy Persons

• Sponsor: Regional Hospital Holstebro (Other)
• Overall Status: Completed
• CT.gov ID: NCT00857909
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 3
• Duration (Months): 17.9
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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; Drug: 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 Design

• Study Type: Interventional
• 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: Jan 1, 2009
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

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; Placebo

Outcome Measures

Primary Outcome Measures

1. Blood pressure [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy

• Non-smokers

Exclusion Criteria:

• Smoking

• Under medical treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Research	Holstebro		Denmark	7500

Sponsors and Collaborators

• Regional Hospital Holstebro

Investigators

• Principal Investigator: Erling B Pedersen, Prof, Regional Hospital Holstebro

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00857909
• Other Study ID Numbers: MED.RES:HOS:SKM.02.2009
• First Posted: Mar 9, 2009
• Last Update Posted: Jul 8, 2011
• Last Verified: Jul 1, 2011

• Additional relevant MeSH terms: Hypertension; Amiloride; Spironolactone

Study Results

No Results Posted as of Jul 8, 2011