Genetic Mechanisms in Human Hypertension Renin-angiotensi... | NCT01009944

Studies
Genetic Mechanisms in Human Hypertension Renin-angiotensin-aldosterone System (RAAS) Inhibition Study

NCT01009944

Sponsor

Brigham and Women's Hospital

Status

Withdrawn

Last Update Posted

Apr 9, 2021Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Hypertension

Interventions

Lisinopril, Atenolol

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

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

Apr 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not funded.

Expanded Access Info

Start Date

Jan 2007Actual

Primary Completion Date

Mar 19, 2019Actual

Completion Date

Mar 19, 2019Actual

First Submitted Date

Nov 6, 2009

First Submission Date that Met QC Criteria

Nov 6, 2009

First Posted Date

Nov 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

Apr 7, 2021

Last Update Posted Date

Apr 9, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gordon H. Williams, MD, Chief, Cardiovascular Endocrinology Section, Brigham and Women's HospitalPrincipal Investigator

Lead Sponsor

Brigham and Women's HospitalOTHER

Collaborators

Name	Class
University of Utah	OTHER

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 purpose of this study is to develop an approach to provide personalized medicine to individuals who have hypertension (high blood pressure). The investigators plan to use people's genetic characteristics (traits) to determine what medication they should use to lower their blood pressure most effectively. The investigators will give individuals one of two medications to treat hypertension (lisinopril or atenolol). The investigators believe that depending on the individuals genetic background one medication will work better in lowering their blood pressure.

Detailed Description

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lisinopril, Atenolol	Experimental		Drug: Lisinopril, Atenolol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lisinopril, Atenolol	Drug	once a day for 14 weeks	Lisinopril, Atenolol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
One type of blood pressure medication will better treat individuals with certain genetic backgrounds.		16 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female hypertensive participants who were previously studied in SCOR program.

Exclusion Criteria:

Diabetes
Taking other medications beside thyroid or estrogen supplements.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 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
Gordon H. Williams, MD	Brigham and Women's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brigham and Women's Hospital		Boston	Massachusetts	02115	United States

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
D017706	Lisinopril
D001262	Atenolol

Ancestor Terms

ID	Term
D004151	Dipeptides
D009842	Oligopeptides
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided