The Effects of Amiloride and Spironolactone on Renophysio... | NCT01195805

Studies
The Effects of Amiloride and Spironolactone on Renophysiological and Cardiovascular Variables

NCT01195805

Sponsor

Regional Hospital Holstebro

Status

Completed

Last Update Posted

Aug 20, 2015Estimated

Enrollment

25Estimated

Phase

Not Applicable

Conditions

Essential Hypertension

Interventions

Spironolactone
Placebo
Amiloride

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

Mar 2013

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

Aug 2010

Primary Completion Date

Aug 2015Actual

Completion Date

Aug 2015Actual

First Submitted Date

Sep 3, 2010

First Submission Date that Met QC Criteria

Sep 3, 2010

First Posted Date

Sep 6, 2010Estimated

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

Aug 19, 2015

Last Update Posted Date

Aug 20, 2015Estimated

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

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.

Detailed Description

Purpose of the study is to examine the effect of amiloride and spironolactone on

Renal function (GFR, u-AQP2, u-ENaCβ, u-cAMP, u-PGE2, CH20, FENa, FEK),
Pulsewave velocity, augmentation index central bloodpressure,
Vasoactive hormones (PRC, AngII, Aldo, AVP, ANP, BNP and Endot), and
Ambulatory bloodpressure

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Amiloride	Active Comparator		Drug: Amiloride
Spironolactone	Active Comparator		Drug: Spironolactone
Placebo	Placebo Comparator	1 tablet twice a day for 28 days	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Spironolactone	Drug	1 tablet twice a day for 28 days	Spironolactone

Measure	Description	Time Frame
Bloodpressure		24-hours and examination

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Smoking
Not using contraceptives
Other illnesses
Drug or alcohol abuse

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Solveig K Matthesen, MD	Departments of medical research and medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Departments of medical research and medicine		Holstebro		7500	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D000075222	Essential Hypertension

Ancestor Terms

ID	Term
D006973	Hypertension
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013148	Spironolactone
D000584	Amiloride

Ancestor Terms

ID	Term
D007783	Lactones
D009930	Organic Chemicals
D011283	Pregnenes
D011278	Pregnanes
D013256

Browse Leaves

Not provided

Browse Branches

Not provided