Trial · NCT00717860

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

NCT00717860, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2011-08-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Clinical Study of MK0991 (Caspofungin) in Japanese Patients With Deep-seated Candida or Aspergillus Infections (0991-062)(COMPLETED). Trials, record NCT00717860. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00717860

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Clinical Study of MK0991 (Caspofungin) in Japanese Patients With Deep-seated Candida or Aspergillus Infections (0991-062)(COMPLETED)
NCT number: NCT00717860
Status: Completed
Phases: Phase 3
Enrollment: 121 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Fungal Infection
Interventions: caspofungin acetate, Comparator: Micafungin sodium
First posted: 2008-07-18
Last updated: 2017-03-23
Results first posted: 2011-08-26

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With a Significant Drug-related Adverse Experience	1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis	A significant drug-related adverse experience was defined as a serious drug-related adverse experience or a drug-related adverse experience leading to study therapy discontinuation.
Secondary	Number of Participants With a Specific Safety Finding	1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis	A specific safety finding was defined as a drug-related adverse experience, a serious drug-related adverse experience, or a drug-related adverse experience leading to study therapy discontinuation.
Secondary	Number of Participants With Favorable Overall Response at the End of Study Therapy	1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis	Favorable overall response for each infection category of deep-seated fungal infections was based on the determination of the Independent Efficacy Assessment Committee.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With a Significant Drug-related Adverse Experience	1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis	All Participants as Treated (APaT) population.	Participants	NUMBER
SECONDARY	Number of Participants With a Specific Safety Finding	1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis	APaT population.	Participants	NUMBER
SECONDARY	Number of Participants With Favorable Overall Response at the End of Study Therapy	1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis	Per Protocol Set (PPS) population.	Participants	NUMBER

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With a Significant Drug-related Adverse Experience	Caspofungin		3	Participants
Number of Participants With a Significant Drug-related Adverse Experience	Micafungin		6	Participants
Number of Participants With a Specific Safety Finding	Caspofungin	Drug-related adverse experience	23	Participants
Number of Participants With a Specific Safety Finding	Micafungin	Drug-related adverse experience	25	Participants
Number of Participants With a Specific Safety Finding	Caspofungin	Serious drug-related adverse experience	0	Participants
Number of Participants With a Specific Safety Finding	Micafungin	Serious drug-related adverse experience	2	Participants
Number of Participants With a Specific Safety Finding	Caspofungin	Discontinued by drug-related adverse experience	3	Participants
Number of Participants With a Specific Safety Finding	Micafungin	Discontinued by drug-related adverse experience	6	Participants
Number of Participants With Favorable Overall Response at the End of Study Therapy	Caspofungin	Esophageal candidiasis (n=6, n=6)	6	Participants
Number of Participants With Favorable Overall Response at the End of Study Therapy	Micafungin	Esophageal candidiasis (n=6, n=6)	5	Participants

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Caspofungin	61
Overall Study	STARTED	Micafungin	60
Overall Study	COMPLETED	Caspofungin	34
Overall Study	COMPLETED	Micafungin	32
Overall Study	NOT COMPLETED	Caspofungin	27
Overall Study	NOT COMPLETED	Micafungin	28

Source ClinicalTrials.gov

Adverse events106

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Constipation	Gastrointestinal disorders	Caspofungin	6	60	7
other	Constipation	Gastrointestinal disorders	Micafungin	5	60	5
other	Diarrhoea	Gastrointestinal disorders	Caspofungin	3	60	3
other	Diarrhoea	Gastrointestinal disorders	Micafungin	7	60	7
other	Nausea	Gastrointestinal disorders	Caspofungin	5	60	5
other	Nausea	Gastrointestinal disorders	Micafungin	4	60	5
other	Vomiting	Gastrointestinal disorders	Caspofungin	4	60	4
other	Vomiting	Gastrointestinal disorders	Micafungin	2	60	3
other	Injection site pain	General disorders	Caspofungin	4	60	4
other	Injection site pain	General disorders	Micafungin	5	60	7

1 to 10 of 106Source ClinicalTrials.gov

See all 106 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Caspofungin
Total, all-cause mortality	Micafungin
Total, other adverse events	Caspofungin	44	60
Total, other adverse events	Micafungin	40	60
Total, serious adverse events	Caspofungin	12	60
Total, serious adverse events	Micafungin	14	60

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23052987	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Caspofungin vs Micafungin: Number of Participants With a Significant Drug-related Adverse Experience	Trial comparisons
Caspofungin vs Micafungin: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00717860

GET https://conductscience.org/api/trials/v1/NCT00717860/events?page=2

API reference For AI assistants