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Sildenafil for Early Pulmonary Vascular Disease in Scleroderma

Study acronym: SEPVADIS
StatusRecruiting
PhasePhase 2
Started2021-09-20
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Sep 1, 2026 → Nov 1, 2026
See other at-risk trials from Johns Hopkins University

Amendment history

2026-09-29
Primary completion pushed: 2026-09-01 → 2026-11-01
Completion pushed: 2026-09-01 → 2026-11-01
2025-10-13
Study Status v7
Primary completion date2025-09-01→2026-09-01
Completion date2025-09→2026-09-01
2024-11-01
Study Status, Contacts/Locations v6
Primary completion date2024-09→2025-09-01
Completion date2024-09→2025-09
2024-09-16
Study Status, Sponsor/Collaborators v5
Collaborators1 to 2 entries
United States Department of Defense
2023-09-12
2 amendments v3-v4
2 re-verifications since 2022-09-08, no change to tracked fields
Show 2 earlier versions
2021-09-21
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-09→confirmed 2021-09-20
Study sitesdetails revised at 2 of 2 sites
2021-08-24
Study Status, Outcome Measures v1
Start date2021-03→2021-09
Secondary endpoints12 entries, revised
Difference in change in health related quality of life as assessed by the 36-Item Short Form Health Survey (SF36) questionnaire Difference in change in health related quality of life as assessed by the emPHasis-10 health-related quality of life questionnaire (emPHasis-10).
2021-03-11
Original filing
This is a Phase II randomized, double-blind, placebo-controlled trial of sildenafil in men and women with Scleroderma with mildly elevated pulmonary pressures (SSc-MEP) to determine whether sildenafil may be an effective treatment for SSc-MEP.
Trial Details
NCT Number NCT04797286
Lead Sponsor Johns Hopkins University
Collaborators: Louisiana State University Health Sciences Center in New Orleans, United States Department of Defense
Conditions Scleroderma, Mildly Elevated Pulmonary Pressures
Enrollment 30 participants
Start Date 2021-09-20
Primary Completion 2026-11-01 (estimated)
Study Completion 2026-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-28