The Effect of Amiloride and Spironolactone in Healthy Per... | NCT00857909

Studies
The Effect of Amiloride and Spironolactone in Healthy Persons

NCT00857909

Sponsor

Regional Hospital Holstebro

Status

Completed

Last Update Posted

Jul 8, 2011Estimated

Enrollment

30Actual

Phase

Phase 1

Conditions

High Blood Pressure

Interventions

Amiloride
Spironolactone
Placebo
Placebo and spironolactone
Spironolactone

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Mar 6, 2009

First Submission Date that Met QC Criteria

Mar 6, 2009

First Posted Date

Mar 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2011

Last Update Posted Date

Jul 8, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Randomisation 1	Active Comparator	Amiloride 5 mg twice daily for 28 days, later compared with spironolactone and placebo	Drug: Amiloride Drug: 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

Name	Type	Description	Arm Group Labels	Other Names
Amiloride	Drug	1 tablet twice a day	Randomisation 1
Spironolactone

Measure	Description	Time Frame
Blood pressure		2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy
Non-smokers

Exclusion Criteria:

Smoking
Under medical treatment

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erling B Pedersen, Prof	Regional Hospital Holstebro	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Research		Holstebro		7500	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000584	Amiloride
D013148	Spironolactone

Ancestor Terms

ID	Term
D011719	Pyrazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D007783	Lactones

Browse Leaves

Not provided

Browse Branches

Not provided