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NCT01305252 · ClinicalTrials.gov registry record · Phase 4
A 48-week Study of the Effect of Dual Therapy (Inhaled Treprostinil and Tadafafil) Versus Monotherapy (Tadalafil).
A Phase 4 study, sponsored by Stanford University.
- Completed
- Registry status
- Phase 4
- Development phase
- 21
- Enrollment target
NCT01305252: Completed Phase 4 study, sponsored by Stanford University.
NCT01305252 is a Phase 4 study that has completed, run by Stanford University. The registered enrollment target is 21 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01305252, a Phase 4 study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 21 participants
- Enrollment target
Study Summary
The Study Hypothesis: Aggressive, upfront, dual therapy for treatment-naïve NYHA I/II/III PAH is superior to a traditional "step-up" approach. The study will evaluate: 1. Impact of dual, upfront, therapy on cardiovascular parameters in PAH as gauged by cardiac magnetic resonance imaging (cMRI) at 24 weeks and event free survival at outcome at 48 weeks. 2. Value of novel biomarkers (NT-pro BNP, Mts1/S100A4, and insulin resistance) and cutting-edge imaging technologies (cardiac MRI) as newer endpoints for clinical trials in PAH. 3. Utility of longer clinical trial design with the use of combined clinical events as time to clinical worsening surrogate
Interventions
- DRUG tadalafil
- DRUG treprostinil inhalations
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2010-07 |
| Est. Completion | 2014-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01305252
The ClinicalTrials.gov registry entry for NCT01305252 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which tadalafil is the first listed.
NCT01305252 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01305252 about?
NCT01305252 is a clinical study titled "A 48-week Study of the Effect of Dual Therapy (Inhaled Treprostinil and Tadafafil) Versus Monotherapy (Tadalafil).". The Study Hypothesis: Aggressive, upfront, dual therapy for treatment-naïve NYHA I/II/III PAH is superior to a traditional "step-up" approach. The study will evaluate: 1. Impact of dual, upfront, therapy on cardiovascular parameters in PAH as gauged by cardiac magnetic resonance imaging (cMRI) at...
What is the current status of trial NCT01305252?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 21 participants. The study started on 2010-07. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01305252?
The interventions under investigation include: tadalafil (DRUG), treprostinil inhalations (DRUG).
Who is sponsoring clinical trial NCT01305252?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
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