Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy

Keywords

Hemodynamics and arterial function of healthy females

Outcome Measures

Primary Outcomes (1)

Hemodynamical effects of Ritodrine and Atosiban in comparison of those of placebo.
240 minutes

Secondary Outcomes (5)

Effect of the specific dosing levels of the medications on the level of arterial stiffness
240 minutes
Effect of the specific dosing levels of the medications on the effects of the peripheral pulse wave reflections on the central, systolic blood pressure
240 minutes
Effect of the specific dosing levels of the medications on the distensibility of the blood vessel wall
240 minutes
Effect of the specific dosing levels of the medications on the cardiac output and total peripheral resistance
240 minutes
Effect of the specific dosing levels of the medications on peripheral brachial, systolic and diastolic blood pressure
240 minutes

Study Arms (3)

1

EXPERIMENTAL

Ritodrine (Pre-Par)

Drug: Ritodrine

2

EXPERIMENTAL

Atosiban (Tractocile)

Drug: Atosiban

3

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

RitodrineDrug

Ritodrine (Pre-Par), maximum 400 µg/minute, IV

AtosibanDrug

Atosiban (Tractocile), maximum 300 µg/minute, IV

Eligibility Criteria

Age20 Years - 40 Years

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Age between 20 and 40 years old;
In good health, especially no cardiovascular diseases, obstructive lung diseases, chronic kidney diseases or diabetes mellitus.

Sponsors & Collaborators

University Hospital, Ghent
Otherlead

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

MeSH Terms

Interventions

Ritodrineatosiban

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesPhenethylaminesEthylamines

Study Officials

Luc Van Bortel, MD, PhD
University Hospital, Ghent
PRINCIPAL INVESTIGATOR

Enrollment

23 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: OTHER

Study Record Dates

First Submitted

May 15, 2008

First Posted

May 19, 2008

Study Start

May 2008

Date type not reported

This date has not been verified as actual or estimated.

Influence of Tocolytical Medications on Hemodynamics (Central and Peripheral) and Vascular Function in a Pilot Study to Determine the Design of the Final Study and the Final Study Itself

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (3)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (3)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations