Sildenafil for Early Pulmonary Vascular Disease in Scleroderma

Part of paid clinical trials in New Orleans, Louisiana.

Sponsor
Johns Hopkins University
Study ID
NCT04797286
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sildenafil — DRUG
    Sildenafil 20 mg three times a day. This is the approved dose for the treatment of pulmonary arterial hypertension. It is being studied in this trial with a population who has mildly elevated pulmonary pressures.
  • Placebo — OTHER
    Oral pill placebo.

Study Details

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.

Key Dates

Start date
Sep 20, 2021
Status verified
Oct 2025
Primary completion
Sep 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sildenafil
    Sildenafil 20 mg by mouth three(3) times each day
  • Placebo Comparator: Placebo
    Placebo by mouth three(3) times each day

Primary Outcome Measure

Difference in change in distance walked in 6 minute walk test (6MWT) at 4 months [ Time Frame: Baseline and 4 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Louisiana State UniversityNew OrleansLouisiana70806
Matthew Lammi, MD
504-568-4634
Marie Sandi
[email protected]
Matthew Lammi, MD (PRINCIPAL_INVESTIGATOR)
Johns HopkinsBaltimoreMaryland21287
Stephen Mathai, MD
[email protected]
410-614-6311
Dezeray Dutton
[email protected]
4435078222
Stephen Mathai, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Louisiana State University· New Orleans, LAJohns Hopkins· Baltimore, MD

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