Study of Amiloride on Vascular Phenotypes in Young Adults... | NCT01308983

Studies
Study of Amiloride on Vascular Phenotypes in Young Adults With Prehypertension

NCT01308983

Sponsor

Augusta University

Status

Unknown status

Last Update Posted

Oct 23, 2012Estimated

Enrollment

32Estimated

Phase

Phase 4

Conditions

Prehypertension

Interventions

Amiloride

Countries

United States

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Dec 2012Estimated

Completion Date

Not provided

First Submitted Date

Mar 2, 2011

First Submission Date that Met QC Criteria

Mar 3, 2011

First Posted Date

Mar 4, 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

Oct 22, 2012

Last Update Posted Date

Oct 23, 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

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

32Estimated

Label	Type	Description	Intervention Names
Amiloride	Other		Drug: Amiloride

Name	Type	Description	Arm Group Labels	Other Names
Amiloride	Drug	Amiloride 10 mg orally once a day for 16 weeks	Amiloride

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vascular phenotypes	(Flow mediated dilation, Pulse wave velocity, and carotid artery compliance)	16 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Prehypertensive: Having systolic BP between 120 to 139 mmHg and/or diastolic BP between 80 to 89 mmHg during screening visit. BP will be measured manually tree times at 10 minutes interval after subjects sit quietly for at least 5 minutes in a chair. The average of last two BP measurements will be taken into consideration.
Male or female of Caucasian or African-American origin.
No history of any major past and current medical illness (such as diabetes, renal disease, liver disease etc.)
Not taking any medication that affects blood pressure.

Exclusion Criteria:

HbA1C > 7.0 % during screening visit.
Serum potassium > 5.5 mEq/L during screening and/or any testing visit due to risk of developing hyperkalemia.
Serum creatinine > 1.5 mg/100 ml and/or creatinine clearance < 50 ml/min* (Glomerular Filtration Rate Estimate by Abbreviated MDRD Study Equation)35 during screening and/or any testing visit due to risk of developing renal dysfunction.
Female having positive pregnancy test during screening and/or any testing visit.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Samip J Parikh, MBBS, MPH	Contact	7067211764		sparikh@georgiahealth.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Georgia Prevention Institute	Recruiting	Augusta	Georgia	30912	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24410943	Derived	Bhagatwala J, Harris RA, Parikh SJ, Zhu H, Huang Y, Kotak I, Seigler N, Pierce GL, Egan BM, Dong Y. Epithelial sodium channel inhibition by amiloride on blood pressure and cardiovascular disease risk in young prehypertensives. J Clin Hypertens (Greenwich). 2014 Jan;16(1):47-53. doi: 10.1111/jch.12218. Epub 2013 Oct 31.

Type	Date	Date Unknown
Release	Aug 29, 2016
Reset	Oct 19, 2016

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

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