NCT01388088

Brief Summary

The investigators wish to investigate the potential effects of potassium. In this study we will examine patients with hypertension and increase their potassium-levels using Amiloride and Spironolactone. The investigators will examine the changes in the cardiovascular system using a Sphygmocor-scanner.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Sep 2010

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

First Submitted

Initial submission to the registry

May 19, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
10 months until next milestone

First Posted

Study publicly available on registry

July 6, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

March 28, 2012

Status Verified

March 1, 2012

Enrollment Period

1.4 years

First QC Date

May 19, 2010

Last Update Submit

March 27, 2012

Conditions

Hypertension

Keywords

HypertensionPotassiumBlood-pressure

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    24 hours blood pressure measurements

    2 years

Secondary Outcomes (1)

  • Pulse wave velocity

    2 years

Study Arms (3)

Spironolactone

ACTIVE COMPARATOR

Increases the level of potassium

Drug: Spironolactone

Amiloride

ACTIVE COMPARATOR

Increases the level of potassium

Drug: Amiloride

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

SpironolactoneDRUG

25 mg twice a day

Spironolactone
AmilorideDRUG

5 mg twice a day

Amiloride
PlaceboDRUG

twice a day

Placebo

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hypertension
  • Age 45-70
  • BMI: 18,5-30

You may not qualify if:

  • Other diseases
  • Drug or alcohol abuse
  • Abnormal findings in the screening procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical Research

Holstebro, 7500, Denmark

Location

MeSH Terms

Conditions

Hypertension

Interventions

SpironolactoneAmiloride

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Solveig K Matthesen, Cand.Med

    Medical Research Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Proffesor

Study Record Dates

First Submitted

May 19, 2010

First Posted

July 6, 2011

Study Start

September 1, 2010

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

March 28, 2012

Record last verified: 2012-03

Locations

DK(1)