NCT05069779

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1 healthy

Timeline
Completed

Started Aug 2017

Typical duration for early_phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2019

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
Last Updated

October 6, 2021

Status Verified

September 1, 2021

Enrollment Period

1.8 years

First QC Date

September 15, 2021

Last Update Submit

September 24, 2021

Conditions

Healthy

Keywords

Blood pressureBenzodiazepineAutonomic nervous system

Outcome Measures

Primary Outcomes (2)

  • 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 (2)

  • Muscle sympathetic nerve activity

    Change from baseline at 60 min

  • Baroreflex sensitivity

    Change from baseline at 60 min

Study Arms (2)

Diazepam

EXPERIMENTAL

Oral

Drug: Diazepam

Placebo

PLACEBO COMPARATOR

Oral

Drug: Diazepam

Interventions

DiazepamDRUG

Oral administration of 10 mg of diazepam

DiazepamPlacebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Brasilia

Brasília, Federal District, 70910-900, Brazil

Location

MeSH Terms

Interventions

Diazepam

Intervention Hierarchy (Ancestors)

BenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2021

First Posted

October 6, 2021

Study Start

August 1, 2017

Primary Completion

May 20, 2019

Study Completion

May 20, 2019

Last Updated

October 6, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations

BR(1)