Diazepam and Blood Pressure Regulation | NCT05069779

Studies
Diazepam and Blood Pressure Regulation

NCT05069779

Sponsor

University of Brasilia

Status

Completed

Last Update Posted

Oct 6, 2021Actual

Enrollment

40Actual

Phase

Early Phase 1

Conditions

Healthy

Interventions

Diazepam

Countries

Brazil

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

Sep 2021

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 1, 2017Actual

Primary Completion Date

May 20, 2019Actual

Completion Date

May 20, 2019Actual

First Submitted Date

Sep 15, 2021

First Submission Date that Met QC Criteria

Sep 24, 2021

First Posted Date

Oct 6, 2021Actual

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

Sep 24, 2021

Last Update Posted Date

Oct 6, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to determine the acute effects of diazepam on beat-to-beat blood pressure variability and baroreflex control.

Detailed Description

Benzodiazepines are widely prescribed for a variety of clinical conditions. However, its cardiovascular consequences remain controversial. In this study, the investigators sought to determine the acute effects of a single dose of oral diazepam (10mg) on resting beat-to-beat blood pressure variability and cardiac and sympathetic baroreflex sensitivity in a cohort of young, healthy individuals.

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diazepam	Experimental	Oral	Drug: Diazepam
Placebo	Placebo Comparator	Oral	Drug: Diazepam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diazepam	Drug	Oral administration of 10 mg of diazepam	Diazepam Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Resting beat-to-beat blood pressure variability	Finger photoplethysmography	Change from baseline at 60 min
Systolic and diastolic blood pressure	Oscillometric device	Change from baseline at 60 min

Secondary Outcomes

Measure	Description	Time Frame
Muscle sympathetic nerve activity	Microneurography	Change from baseline at 60 min
Baroreflex sensitivity	The relationship between changes in beat-to-beat blood pressure and heart rate (cardiac baroreflex) or MSNA (sympathetic baroreflex).

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 to 40 years of age
Healthy, free of known cardiovascular, metabolic, or musculoskeletal disease

Exclusion Criteria:

History of smoking (tobacco or cannabis), defined as any smoking within the past 3 months
Diagnosed cardiovascular or metabolic disease(s)
Prescription of chronic medications other than oral contraceptives
History of hypertension or presence of arrhythmia

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Brasilia		Brasília	Federal District	70910-900	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The data underlying this project will be shared on reasonable request to the principal investigator.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003975	Diazepam

Ancestor Terms

ID	Term
D001570	Benzodiazepinones
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring

Browse Leaves

Not provided

Browse Branches

Not provided