NCT00857909

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 9, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

July 8, 2011

Status Verified

July 1, 2011

Enrollment Period

1.5 years

First QC Date

March 6, 2009

Last Update Submit

July 7, 2011

Conditions

High Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    2 years

Study Arms (3)

Randomisation 1

ACTIVE COMPARATOR

Amiloride 5 mg twice daily for 28 days, later compared with spironolactone and placebo

Drug: AmilorideDrug: Placebo and spironolactone

Randomisation 2

ACTIVE COMPARATOR

Spironolactone 25 mg twice daily, to be compared with placebo and amiloride

Drug: Spironolactone

Placebo

PLACEBO COMPARATOR

calcium tablet

Drug: Placebo

Interventions

AmilorideDRUG

1 tablet twice a day

Randomisation 1
SpironolactoneDRUG

1 tablet twice a day

Randomisation 2
PlaceboDRUG

Placebo

Placebo
Placebo and spironolactoneDRUG

5mg twice daily

Randomisation 1

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Non-smokers

You may not qualify if:

  • Smoking
  • Under medical treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Research

Holstebro, 7500, Denmark

Location

MeSH Terms

Conditions

Hypertension

Interventions

AmilorideSpironolactone

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PyrazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsLactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Erling B Pedersen, Prof

    Regional Hospital Holstebro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 6, 2009

First Posted

March 9, 2009

Study Start

January 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

July 8, 2011

Record last verified: 2011-07

Locations

DK(1)