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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00679705
First Posted: May 19, 2008
Last Update Posted: April 20, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Ghent
  Purpose

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).


Condition Intervention Phase
Healthy Drug: Ritodrine Drug: Atosiban Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pilot Study: A Dose-Response Finding Study of Ritodrine (Pre-Par®) to Find the Highest Well Tolerated Dose in Young, Healthy, Female Volunteers. To Find the Size-Order of the Hemodynamical Effects of Ritodrine (PrePar®) and Atosiban (Tractocile®) to Determine the Relevance of a PK/PD-Modelling in the Final Study. Final Study: Investigating the Influence of Tocolytical Medications: Ritodrine (PrePar®) and Atosiban (Tractocile®) at the Clinical Dose on the Hemodynamics and Arterial Function in Healthy Female Volunteers, Compared to Placebo During Continuous Intravenous Infusion.

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Hemodynamical effects of Ritodrine and Atosiban in comparison of those of placebo. [ Time Frame: 240 minutes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 23
Study Start Date: May 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Ritodrine (Pre-Par)
Drug: Ritodrine
Ritodrine (Pre-Par), maximum 400 µg/minute, IV
Experimental: 2
Atosiban (Tractocile)
Drug: Atosiban
Atosiban (Tractocile), maximum 300 µg/minute, IV
Placebo Comparator: 3
Placebo
Drug: Placebo
Glucose 5%, IV

  Eligibility

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00679705


Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Luc Van Bortel, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
Responsible Party: Luc Van Bortel, MD, PhD, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00679705     History of Changes
Other Study ID Numbers: 2008/110
First Submitted: May 15, 2008
First Posted: May 19, 2008
Last Update Posted: April 20, 2009
Last Verified: April 2009

Keywords provided by University Hospital, Ghent:
Hemodynamics and arterial function of healthy females

Additional relevant MeSH terms:
Atosiban
Ritodrine
Vasotocin
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Tocolytic Agents
Reproductive Control Agents
Oxytocics
Vasoconstrictor Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action