Cardiovascular and Sympathomimetic Effects Sample Clauses

Cardiovascular and Sympathomimetic Effects. The full dose of 125 mg, followed by a supplemental dose of 62.5 mg after 1.5 to 2.5 hours, is expected to produce significant but transient, self-limited increases in blood pressure and heart rate. These changes should last no more than six hours. In less than 5% of volunteers in Phase 1 studies, peak blood pressure values were higher than 140/90 mmHg. Clinical intervention was not required in any of these cases. Nonetheless, careful monitoring of subjects and predefined contingency plans will allow the researchers to rapidly identify and manage any related toxicity. For more information, see the sponsor’s IB. Risks posed by elevated blood pressure will be addressed by excluding people with pre- existing hypertension and monitoring blood pressure and pulse, as described in Section
Sample 1
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Cardiovascular and Sympathomimetic Effects. The full dose of 125 mg, followed by a supplemental dose of 62.5 mg after 1.5 to 2.5 hours, is expected to produce significant but transient, self-limited increases in blood pressure and heart rate. These changes should last no more than six hours. In less than 5% of volunteers in Phase 1 studies, peak blood pressure values were higher than 140/90 mmHg. Clinical intervention was not required in any of these cases. Nonetheless, careful monitoring of participants and predefined contingency plans will allow the researchers to rapidly identify and manage any related toxicity. For more information, see the sponsor’s Investigator Brochure. Risks posed by elevated blood pressure will be addressed by excluding people with pre- existing hypertension and monitoring blood pressure and pulse as described in Section
Sample 1

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