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Sildenafil for Scleroderma (SEPVADIS Trial)

Phase 2
Recruiting
Led By Stephen Mathai, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pulmonary function tests with forced expiratory volume in one second/forced vital capacity (FEV1/FVC) >50% AND either a) total lung capacity (TLC) or forced vital capacity (FVC) > 70% predicted or b) TLC or FVC between 60% and 70% predicted with no more than mild interstitial lung disease on computerized tomography scan of the chest on studies obtained within 6 months of enrollment.
Ventilation perfusion scan or computed tomography with intravenous contrast (CT angiogram) without evidence of chronic thromboembolism at anytime before study entry.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ongoing until study closes, up to 4 years
Awards & highlights

SEPVADIS Trial Summary

This trial is testing whether sildenafil is an effective treatment for Scleroderma with mildly elevated pulmonary pressures.

Who is the study for?
This trial is for men and women with Scleroderma who have mildly elevated pulmonary pressures. Participants must meet specific criteria including a diagnosis of SSc, the ability to perform certain lung function tests, and not be severely ill or hospitalized. They should not be on other investigational drugs or PAH therapy recently, nor have significant heart issues or untreated sleep apnea.Check my eligibility
What is being tested?
The study is testing sildenafil against a placebo in patients with Scleroderma to see if it can effectively treat mildly elevated pulmonary pressures. It's a Phase II trial where participants are randomly assigned to either the medication or an inactive substance without knowing which one they receive.See study design
What are the potential side effects?
Sildenafil may cause headaches, flushing, indigestion, nasal congestion, dizziness, vision changes like blurring or color tingeing. In rare cases it might lead to more serious effects such as severe allergic reactions or prolonged erections.

SEPVADIS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung function tests show I have more than half the normal breathing capacity.
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My scans show no signs of chronic blood clots.
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I can walk for six minutes without difficulty.

SEPVADIS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~ongoing until study closes, up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and ongoing until study closes, up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in change in distance walked in 6 minute walk test (6MWT) at 4 months
Secondary outcome measures
Nesiritide
Difference in change in distance walked in 6MWT at 12 months
Difference in change in health related quality of life as assessed by the 36-Item Short Form Health Survey (SF36) questionnaire
+6 more

Side effects data

From 2018 Phase 4 trial • 6 Patients • NCT01642407
50%
Bronchitis
50%
Nasopharyngitis
50%
Upper respiratory tract infection
33%
Headache
33%
Epistaxis
33%
Diarrhoea
33%
Gastroenteritis
17%
Vision blurred
17%
Eczema
17%
Rash
17%
Flushing
17%
Alanine aminotransferase increased
17%
Ammonia increased
17%
Aspartate aminotransferase increased
17%
Weight increased
17%
Dysmenorrhoea
17%
Erection increased
17%
Pulmonary arterial hypertension
17%
Rhinitis allergic
17%
Acne
17%
Dermatitis diaper
17%
Dry skin
17%
Visual acuity reduced transiently
17%
Colitis
17%
Molluscum contagiosum
17%
Streptococcal infection
17%
Blood urine present
17%
Myalgia
17%
Cardiac failure
17%
Conjunctivitis allergic
17%
Dental caries
17%
Vomiting
17%
Chest pain
17%
Feeling abnormal
17%
Influenza
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sildenafil

SEPVADIS Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SildenafilExperimental Treatment1 Intervention
Sildenafil 20 mg by mouth three(3) times each day
Group II: PlaceboPlacebo Group1 Intervention
Placebo by mouth three(3) times each day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sildenafil
FDA approved

Find a Location

Who is running the clinical trial?

Louisiana State University Health Sciences Center in New OrleansOTHER
114 Previous Clinical Trials
44,171 Total Patients Enrolled
2 Trials studying Scleroderma
86 Patients Enrolled for Scleroderma
Johns Hopkins UniversityLead Sponsor
2,260 Previous Clinical Trials
14,820,750 Total Patients Enrolled
9 Trials studying Scleroderma
497 Patients Enrolled for Scleroderma
Stephen Mathai, MDPrincipal InvestigatorJohns Hopkins University

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04797286 — Phase 2
Scleroderma Research Study Groups: Sildenafil, Placebo
Scleroderma Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04797286 — Phase 2
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04797286 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What additional research has been conducted on the efficacy of Sildenafil?

"Virginia Commonwealth University/Massey Cancer Center first took up the investigation of sildenafil in 2013, and have since conducted a total of 18456 trials. As for current studies, 23 are still live with many being carried out from New Orleans, Louisiana."

Answered by AI

Does this research project still have space for volunteer participants?

"According to the information on clinicaltrials.gov, this research is still accepting participants. It was initially shared on September 20th 2021 and has since been modified as recent as September 8th 2022."

Answered by AI

How extensive is the sample size of this research project?

"Affirmative. According to the clinicaltrials.gov repository, this research project is actively recruiting participants since its first post on September 20th 2021. The total number of patients needed across 2 sites amounts to 30 individuals."

Answered by AI

In what medical contexts is Sildenafil usually prescribed?

"Sildenafil can be used to combat conditions such as premature ejaculation, NYHA functional class II-III pulmonary arterial hypertension, and general pulmonary arterial hypertension."

Answered by AI

Do Sildenafil treatments pose any potential safety risks for patients?

"Although Sildenafil is still being tested, the safety of this medication has been established and thus receives a score of 2."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
How old are they?
18 - 65
What site did they apply to?
Johns Hopkins
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Sildenafil for Early Pulmonary Vascular Disease in Scleroderma
2021. "Sildenafil for Early Pulmonary Vascular Disease in Scleroderma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04797286.
All > Scleroderma Research Foundation > Viagra
~3 spots leftby Sep 2024
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