Phase 3 N=121 Randomized Double-blind Treatment

A Clinical Study of MK0991 (Caspofungin) in Japanese Patients With Deep-seated Candida or Aspergillus Infections (0991-062)(COMPLETED)

Fungal Infection

Bottom Line

View on ClinicalTrials.gov: NCT00717860 ↗

Enrolled (actual)

121

Serious AEs

21.7%

Results posted

Aug 2011

Primary outcome: Primary: Number of Participants With a Significant Drug-related Adverse Experience — 3; 6 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: caspofungin acetate (Drug); Comparator: Micafungin sodium (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Jul 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With a Significant Drug-related Adverse Experience	3; 6	—
SECONDARY Number of Participants With a Specific Safety Finding	23; 25; 0; 2; 3; 6	—
SECONDARY Number of Participants With Favorable Overall Response at the End of Study Therapy	6; 5; 3; 1; 14; 14	—

Summary

The purpose of this study is to investigate the safety and efficacy of MK0991 in patients with deep-seated mycoses.

Eligibility Criteria

Inclusion Criteria

Japanese Patients In Whom A Causative Fungus Is Detected Before Treatment With The Study Drug Or Patients With Strongly Suspected Deep-Seated Fungal Infection Due To Candida species (Spp.) Or Aspergillus Spp.

Exclusion Criteria

Patients With Mycoses Other Than Ones Due To Candida Spp. Or Aspergillus Spp.
Patients Who Will Receive Other Systemic Antifungal Agents For The First Time In Screening Period.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00717860). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.