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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:
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00679705
First received: May 15, 2008
Last updated: April 17, 2009
Last verified: April 2009
History of Changes
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Effect of the specific dosing levels of the medications on the level of arterial stiffness [ Time Frame: 240 minutes ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Effect of the specific dosing levels of the medications on the distensibility of the blood vessel wall [ Time Frame: 240 minutes ] [ Designated as safety issue: Yes ]
  • Effect of the specific dosing levels of the medications on the cardiac output and total peripheral resistance [ Time Frame: 240 minutes ] [ Designated as safety issue: Yes ]
  • Effect of the specific dosing levels of the medications on peripheral brachial, systolic and diastolic blood pressure [ Time Frame: 240 minutes ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   20 Years to 40 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Website of the University Hospital Ghent  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Luc Van Bortel, MD, PhD, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00679705     History of Changes
Other Study ID Numbers: 2008/110
Study First Received: May 15, 2008
Last Updated: April 17, 2009
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

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

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

ClinicalTrials.gov processed this record on May 16, 2013