A Surveillance Study Is Conducted to Assess the Efficacy and Safety

question 44

Multiple Choice

A surveillance study is conducted to assess the efficacy and safety of tolvaptan, a drug currently being used in the clinical setting for treating heart failure with volume overload.  The study enrolls 8,300 patients with a variety of medical comorbidities who received tolvaptan once daily in the morning for 2 weeks.  Results showed that tolvaptan demonstrated aquaretic efficacy in patients with diuretic-resistant volume overload, but that hypernatremia was a complication in a small number of patients.  Researchers recommended a lower dose of tolvaptan in those with normonatremia and hypokalemia to prevent hypernatremia.  Which of the following best describes this type of study?

• A)Preclinical study
• B)Phase I clinical trial
• C)Phase II clinical trial
• D)Phase III clinical trial
• E)Phase IV clinical trial

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Definitions:

Merger or Acquisition

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Joint Goal

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