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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Ritodrine (Pre-Par) |
|
| 2 | Experimental | Atosiban (Tractocile) |
|
| 3 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ritodrine | Drug | Ritodrine (Pre-Par), maximum 400 µg/minute, IV |
| |
| Atosiban |
| Measure | Description | Time Frame |
|---|---|---|
| Hemodynamical effects of Ritodrine and Atosiban in comparison of those of placebo. | 240 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luc Van Bortel, MD, PhD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ghent | Ghent | 9000 | Belgium |
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| Label | URL |
|---|---|
| Website of the University Hospital Ghent | View source |
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| Drug |
Atosiban (Tractocile), maximum 300 µg/minute, IV |
|
| Placebo | Drug | Glucose 5%, IV |
|
| 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 |
| ID | Term |
|---|---|
| D012312 | Ritodrine |
| C047046 | atosiban |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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