drugset / Trial / NCT00679705
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
RandomizedCrossoverDouble-blindTreatment
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).
Timeline
- Start
- 2008-05
- Primary completion
- 2008-11
- Completion
- 2008-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atosiban | Other / unclassified | 300 ug | Intravenous |
| Subject | Ritodrine | Small molecule | 400 ug | Intravenous |
Indications
No indication recorded.