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Aldosterone Receptor Antagonist

Spironolactone for Pulmonary Hypertension

Phase 4
Waitlist Available
Led By Zeenat Safdar, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 week
Awards & highlights
Approved for 10 Other Conditions
Drug Has Already Been Approved
Pivotal Trial
All Individual Drugs Already Approved

Summary

The purpose of this study is to determine the effects of spironolactone on collagen markers in a large number of patients with pulmonary hypertension. In addition, safety and tolerability of spironolactone, an aldosterone receptor antagonist, in patients with pulmonary arterial hypertension, will be determined.

Eligible Conditions
  • Pulmonary Hypertension

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in biomarker levels in the spironolactone treated as compared to placebo treated group.
Secondary study objectives
Composite end-point
Number of adverse events in patients treated with spironolactone as compared to placebo.

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Group I: SpironolactoneExperimental Treatment1 Intervention
Drug: Spironolactone Drug: Placebo
Group II: PlaceboExperimental Treatment1 Intervention
Drug: Placebo Drug: Spironolactone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spironolactone
FDA approved
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,022 Previous Clinical Trials
6,029,211 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,922 Previous Clinical Trials
47,760,688 Total Patients Enrolled
Zeenat Safdar, MDPrincipal InvestigatorBaylor College of Medicine
~3 spots leftby Nov 2025
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