The Effect of Amiloride and Spironolactone in Patients Wi... | NCT01388088

Studies
The Effect of Amiloride and Spironolactone in Patients With Hypertension

NCT01388088

Sponsor

Erling Bjerregaard Pedersen

Status

Completed

Last Update Posted

Mar 28, 2012Estimated

Enrollment

23Actual

Phase

Phase 4

Conditions

Hypertension

Interventions

Spironolactone
Amiloride
Placebo

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 2012

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

Sep 2010

Primary Completion Date

Feb 2012Actual

Completion Date

Feb 2012Actual

First Submitted Date

May 19, 2010

First Submission Date that Met QC Criteria

Jul 3, 2011

First Posted Date

Jul 6, 2011Estimated

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

Mar 27, 2012

Last Update Posted Date

Mar 28, 2012Estimated

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 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.

Detailed Description

Purpose of the study is to examine the effect of amilorid and spironolacton on

Renal function (GFR, u-AQP2, u-ENaCβ, u-cAMP, u-PGE2, CH20, FENa, FEK),
Pulsewavevelocity, augmentation index and centralt bloodpressure,
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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Spironolactone	Drug	25 mg twice a day	Spironolactone
Amiloride

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood pressure	24 hours blood pressure measurements	2 years

Secondary Outcomes

Measure	Description	Time Frame
Pulse wave velocity	We will investigate the changes in cardiovascular variables using a Sphygmocor scanner.	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 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, Cand.Med	Medical Research Department	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of 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
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