Phase 3
Completed N=121
A Clinical Study of MK0991 (Caspofungin) in Japanese Patients With Deep-seated Candida or Aspergillus Infections (0991-062)(COMPLETED)
Source: ClinicalTrials.gov NCT00717860 ↗Enrolled (actual)
121
Serious AEs
21.7%
Results posted
Aug 2011
Primary outcomePrimary: Number of Participants With a Significant Drug-related Adverse Experience — 3; 6 Participants
Summary
The purpose of this study is to investigate the safety and efficacy of MK0991 in patients with deep-seated mycoses.
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 | — |
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.
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. Informational only — not medical advice.