Trial Outcomes & Findings for Chronic Sildenafil for Severe Diaphragmatic Hernia (NCT NCT00133679)

NCT ID: NCT00133679

Last Updated: 2021-01-13

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 9 participants
• Primary outcome timeframe: 7 weeks
• Results posted on: 2021-01-13

Participant Flow

Study was terminated. All efforts to locate the data have been exhausted and data has been lost and/or destroyed.

Participant milestones

Measure	Sildenafil Sildenafil x 45 days sildenafil: Sildenafil 0.5 mg/kg every 6 hours orally x 45 d	Placebo Placebo x 45 d Placebo: Placebo suspension (equal volume to experimental drug) x 45 days
Overall Study STARTED	0	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Chronic Sildenafil for Severe Diaphragmatic Hernia

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 7 weeks

Population: Study was terminated. All efforts to locate the data have been exhausted and data has been lost and/or destroyed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 weeks

Population: Study was terminated. All efforts to locate the data have been exhausted and data has been lost and/or destroyed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Study was terminated. All efforts to locate the data have been exhausted and data has been lost and/or destroyed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Study was terminated. All efforts to locate the data have been exhausted and data has been lost and/or destroyed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Study was terminated. All efforts to locate the data have been exhausted and data has been lost and/or destroyed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Study was terminated. All efforts to locate the data have been exhausted and data has been lost and/or destroyed.

Outcome measures

Outcome data not reported

Adverse Events

Sildenafil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Roberta Keller, MD

University of California, San Francisco

Phone: (415) 476-1888

Email: roberta.keller@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place