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NCT00679705·Phase 1·INTERVENTIONAL

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

AtosibanOtherCompleted

Status

Completed

Phase

Phase 1

Enrollment

23

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

This trial will consist of two parts: A pilot study in a three-way cross over trial to determine the highest well tolerated dose of Ritodrine (Pre-Par®), the impact of Atosiban (Tractocile®) on the hemodynamics and hence the design of the final study. The final study is planned as a three-way crossover trial to investigate and compare the cardiovascular effects of Ritodrine, Atosiban and placebo to relate those effects to the pharmacokinetics of Ritodrine and Atosiban (PK/PD modelling).

Interventions

Treatment arms and agents.

DRUG

Ritodrine

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

DRUG

Atosiban

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

DRUG

Placebo

Glucose 5%, IV

Timeline

From registration to results.

  1. First posted

    May 19, 2008

  2. Study start

    May 2008

  3. Primary completion

    Nov 2008

  4. Study completion

    Nov 2008

  5. Results posted

    Not reported

  6. Registry updated

    Apr 20, 2009

Outcomes

What the study measures.

Primary outcomes

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

Time frame · 240 minutes

Secondary outcomes

Effect of the specific dosing levels of the medications on the level of arterial stiffness

Time frame · 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

Time frame · 240 minutes

Effect of the specific dosing levels of the medications on the distensibility of the blood vessel wall

Time frame · 240 minutes

Effect of the specific dosing levels of the medications on the cardiac output and total peripheral resistance

Time frame · 240 minutes

Effect of the specific dosing levels of the medications on peripheral brachial, systolic and diastolic blood pressure

Time frame · 240 minutes

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
40 Years
Sex
FEMALE
Healthy volunteers
Yes

Inclusion Criteria: * Age between 20 and 40 years old; * In good health, especially no cardiovascular diseases, obstructive lung diseases, chronic kidney diseases or diabetes mellitus. * Using a proper anticonception method (orally, subcutaneously); * A negative pregnancy test. Exclusion Criteria: * Intolerance of Ritodrine; * On chronic medication, except oral and subcutaneous contraception * History or present presentation of cardiac arrythmias; * Risk of being pregnant or less than 6 months postpartum; * Giving breastfeeding; * Previous uteral surgery; * Using an intra-uteral device (IUD); * A severe addiction: nicotine (\> 10 cigarettes/day), alcohol (\> 3 units/day), caffeine (\> 5 units/day) or any extralegally drugs.

Study locations

1 registered sites.

Belgium. Showing up to 24 locations stored in the fast local snapshot.

University Hospital Ghent

Ghent, Belgium

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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More studies on Atosiban.

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Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsAtosiban trial dashboard →DatabaseAtosiban database entry →ResearchAtosiban research guide →