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A 48-week Study of the Effect of Dual Therapy (Inhaled Treprostinil and Tadafafil) Versus Monotherapy (Tadalafil).

NCT01305252 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2017-06-02

Study results available
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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

Conditions

  • Hypertension, Pulmonary

Interventions

DRUG

treprostinil inhalations

Treprostinil inhalation QID starting at 3 breaths per inhalation \& gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.

DRUG

tadalafil

tadalafil 20mg QD PO increasing to 40mg QD as tolerated

Sponsors & Collaborators

Principal Investigators

  • Roham T. Zamanian · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01305252 on ClinicalTrials.gov