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

NCT00679705 | Completed Phase 1

• 1 other identifier: 2008/110
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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).

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

Ritodrine DRUG

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

1

Atosiban DRUG

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

2

Placebo DRUG

Glucose 5%, IV

3

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (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.
• Using a proper anticonception method (orally, subcutaneously);
• A negative pregnancy test.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

• Website of the University Hospital Ghent

MeSH Terms

Interventions

Ritodrine; atosiban

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines

Study Officials

• Luc Van Bortel, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

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 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: April 20, 2009

Record last verified: 2009-04

Locations

BE (1)