Trial · NCT00635648

A Study of Caspofungin Acetate (MK0991) for the Treatment of Esophageal Candidiasis or Invasive Candidiasis in Chinese Adults (MK-0991-066)

NCT00635648, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2012-05-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Caspofungin Acetate (MK0991) for the Treatment of Esophageal Candidiasis or Invasive Candidiasis in Chinese Adults (MK-0991-066). Trials, record NCT00635648. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00635648

On this page

Trial

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

Title: A Study of Caspofungin Acetate (MK0991) for the Treatment of Esophageal Candidiasis or Invasive Candidiasis in Chinese Adults (MK-0991-066)
NCT number: NCT00635648
Status: Completed
Phases: Phase 3
Enrollment: 63 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Fungal Infection
Interventions: caspofungin acetate
First posted: 2008-03-14
Last updated: 2017-03-24
Results first posted: 2012-05-28
Limitations and caveats: This was an open-label non-comparative study with a relatively small sample size.

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Number of Participants With One or More Drug-related Serious Adverse Events	First dose of study drug through 14 days post therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)	A serious adverse event is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the patient and may require medical intervention. A drug-related adverse event is a determination by the investigator physician that the study drug caused the event based on exposure, time course, likely cause, dechallenge (event resolved/improved when drug was discontinued), rechallenge (event resolved/improved when drug was re-introduced), and consistency with the drug profile.
Secondary	Number of Participants With One or More Drug-related Adverse Events	First dose of study drug through 14 days post therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)	A drug-related adverse event is a determination by the investigator physician that the study drug caused the event based on exposure, time course, likely cause, dechallenge (event resolved/improved when drug was discontinued), rechallenge (event resolved/improved when drug was re-introduced), and consistency with the drug profile.
Secondary	Number of Participants Who Discontinued Due to a Drug-related Adverse Event	First dose of study drug through 14 days post therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)	A drug-related adverse event is a determination by the investigator physician that the study drug caused the event based on exposure, time course, likely cause, dechallenge (event resolved/improved when drug was discontinued), rechallenge (event resolved/improved when drug was re-introduced), and consistency with the drug profile.
Secondary	Number of Participants With Favorable Overall Response for Esophageal Candidiasis or Invasive Candidiasis	First dose of study drug through up to 60 days of therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)	Efficacy response for esophageal candidiasis was based on clinical and endoscopic criteria; favorable responses included complete and partial improvement in symptoms and endoscopic lesions. Efficacy response for invasive candidiasis was based on microbiological and clinical assessments; favorable responses required both favorable microbiological response (i.e., eradication or presumptive eradication based on symptoms, physical exam, and non-invasive tests) and complete or partial clinical response.

Source ClinicalTrials.gov

Outcomes4

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 One or More Drug-related Serious Adverse Events	First dose of study drug through 14 days post therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)		Participants	NUMBER
SECONDARY	Number of Participants With One or More Drug-related Adverse Events	First dose of study drug through 14 days post therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)		Participants	NUMBER
SECONDARY	Number of Participants Who Discontinued Due to a Drug-related Adverse Event	First dose of study drug through 14 days post therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)		Participants	NUMBER
SECONDARY	Number of Participants With Favorable Overall Response for Esophageal Candidiasis or Invasive Candidiasis	First dose of study drug through up to 60 days of therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)	Of the 63 enrolled participants, one participant with invasive candidiasis who withdrew consent before completing the efficacy assessment was not included in the efficacy analyses.	Participants	NUMBER

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Units
Number of Participants With One or More Drug-related Serious Adverse Events	Caspofungin 50 mg q.d. IV	0	Participants
Number of Participants With One or More Drug-related Adverse Events	Caspofungin 50 mg q.d. IV	31	Participants
Number of Participants Who Discontinued Due to a Drug-related Adverse Event	Caspofungin 50 mg q.d. IV	1	Participants
Number of Participants With Favorable Overall Response for Esophageal Candidiasis or Invasive Candidiasis	Caspofungin 50 mg q.d. IV	36	Participants

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Caspofungin 50 mg q.d. Intravenous (IV)	63
Overall Study	COMPLETED	Caspofungin 50 mg q.d. Intravenous (IV)	26
Overall Study	NOT COMPLETED	Caspofungin 50 mg q.d. Intravenous (IV)	37

Source ClinicalTrials.gov

Adverse events27

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	Cardiac Failure	Cardiac disorders	Caspofungin 50 mg q.d. IV	4	63	4
other	Abdominal Pain	Gastrointestinal disorders	Caspofungin 50 mg q.d. IV	4	63	4
other	Oedema	General disorders	Caspofungin 50 mg q.d. IV	4	63	4
other	Pyrexia	General disorders	Caspofungin 50 mg q.d. IV	5	63	7
other	Alanine Aminotransferase Increased	Investigations	Caspofungin 50 mg q.d. IV	10	63	10
other	Aspartate Aminotransferase Increased	Investigations	Caspofungin 50 mg q.d. IV	9	63	10
other	Blood Albumin Decreased	Investigations	Caspofungin 50 mg q.d. IV	6	63	6
other	Blood Bilirubin Increased	Investigations	Caspofungin 50 mg q.d. IV	7	63	11
other	Blood Calcium Decreased	Investigations	Caspofungin 50 mg q.d. IV	5	63	9
other	Blood Creatinine Increased	Investigations	Caspofungin 50 mg q.d. IV	7	63	8

1 to 10 of 27Source ClinicalTrials.gov

See all 27 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Caspofungin 50 mg q.d. IV
Total, other adverse events	Caspofungin 50 mg q.d. IV	43	63
Total, serious adverse events	Caspofungin 50 mg q.d. IV	14	63

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons0

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

None in this release.

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/NCT00635648

GET https://conductscience.org/api/trials/v1/NCT00635648/events?page=2

API reference For AI assistants