NCT01195805

Brief Summary

The investigators wish to study the effect of retaining potassium. The participants have essential hypertension. The test substances are Amiloride, Spironolactone and placebo. The participants will ingest tablets for 28 days before being examined. We will perform a 24 hours urine collection, 24-hours bloodpressure measurement, blood and urine samples and we also examine the patient using a SphygmoCor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2010

Longer than P75 for not_applicable

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

August 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 3, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2010

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 20, 2015

Status Verified

March 1, 2013

Enrollment Period

5 years

First QC Date

September 3, 2010

Last Update Submit

August 19, 2015

Conditions

Essential Hypertension

Keywords

Blood pressure, PWV, HRV, PWV, potassium

Outcome Measures

Primary Outcomes (1)

  • Bloodpressure

    24-hours and examination

Study Arms (3)

Amiloride

ACTIVE COMPARATOR
Drug: Amiloride

Spironolactone

ACTIVE COMPARATOR
Drug: Spironolactone

Placebo

PLACEBO COMPARATOR

1 tablet twice a day for 28 days

Other: Placebo

Interventions

SpironolactoneDRUG

1 tablet twice a day for 28 days

Spironolactone
PlaceboOTHER

1 tablet twice a day for 28 days

Placebo
AmilorideDRUG

1 tablet twice a day for 28 days

Amiloride

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hypertension,
  • BMI 18,5-30,
  • non-smoker

You may not qualify if:

  • Smoking
  • Not using contraceptives
  • Other illnesses
  • Drug or alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departments of medical research and medicine

Holstebro, 7500, Denmark

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

SpironolactoneAmiloride

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Solveig K Matthesen, MD

    Departments of medical research and medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

September 3, 2010

First Posted

September 6, 2010

Study Start

August 1, 2010

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

August 20, 2015

Record last verified: 2013-03

Locations

DK(1)