A Surveillance Study Is Conducted to Assess the Efficacy and Safety

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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