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Trial record 3 of 4 for:    Ambrisentan and Tadalafil | Recruiting, Not yet recruiting, Available Studies

Study to Compare Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial Hypertension

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified May 2017 by United Therapeutics
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT02999906
First received: December 19, 2016
Last updated: May 19, 2017
Last verified: May 2017
  Purpose
This is a multicenter, randomized (2:1 oral treprostinil: placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are currently receiving background dual therapy (ambrisentan, tadalafil) for at least 30 days at randomization for their PAH. Once randomized, subjects will return for 5 study visits up to Week 28 during the blinded period. After the Week 28 Visit, eligible subjects will transition to the open-label period of the study for up to 20 weeks.

Condition Intervention Phase
Pulmonary Arterial Hypertension Drug: Oral Treprostinil Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Compare the Efficacy and Safety of Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial Hypertension

Resource links provided by NLM:


Further study details as provided by United Therapeutics:

Primary Outcome Measures:
  • Change in 6-Minute Walk Distance (6MWD) [ Time Frame: Baseline to Week 28 ]

Secondary Outcome Measures:
  • Compare the effects of triple therapy versus dual therapy on the time to clinical worsening [ Time Frame: Baseline to Week 28 ]

    clinical worsening is defined by 1 of the following:

    • Death (all causes)
    • Hospitalization due to worsening PAH
    • Initiation of long-term parenteral therapy
    • Disease progression
    • Unsatisfactory long-term clinical response

  • Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations From Baseline to Week 28 [ Time Frame: Baseline to week 28 ]
    The level of this biomarker of the (NT-proBNP) serum concentration will be assessed to compare the severity of heart failure at Baseline and Week 28.

  • Number of Participants with a Change From Baseline World Health Organization (WHO) Functional Classification at Week 28. [ Time Frame: Baseline to week 28 ]
    The WHO Functional Class of pulmonary hypertension is a physical activity rating scale as follows: Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms.

  • Change in Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) From Baseline to Week 28. [ Time Frame: Baseline to week 28 ]
    The CAMPHOR is a health related quality of life instrument validated for pulmonary hypertension that assesses impairment (symptoms), disability (activities) and quality of life. The questionnaire is divided into three sections; Symptoms (Scores 025; high scores indicate more symptoms), Activity (Score 030; low score indicates good functioning) and Quality of Life (025; high scores indicate poor QoL). The sum of these scores equates to the Total score (080). In the CAMPHOR scores, lower scores indicate improvements.


Estimated Enrollment: 600
Anticipated Study Start Date: October 2017
Estimated Study Completion Date: June 2022
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Matching placebo (sugar pill)
Drug: Placebo
Placebo (sugar pill) for three times daily oral administration
Other Name: matching placebo (sugar pill)
Active Comparator: Active
Oral treprostinil sustained release tablet
Drug: Oral Treprostinil
Sustained release oral tablets for three times daily administration
Other Name: treprostinil diethanolamine

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Between 18 and 79 years of age, inclusive
  2. PAH that is idiopathic / heritable, PAH associated with connective tissue disease, HIV infection, repaired congenital systemic-to-pulmonary shunts (repaired > 1 year), or appetite suppressant / toxin use
  3. Receiving dual therapy (ambrisentan and tadalafil)
  4. Previous testing (e.g. right heart catheterization, echocardiography) consistent with diagnosis of PAH

Exclusion Criteria:

  1. Nursing or pregnant
  2. PAH due to conditions other than noted in the above inclusion criteria
  3. Received PAH-specific drug therapy for >2 years
  4. History of uncontrolled sleep apnea, severe liver disease, severe renal impairment, left sided heart disease, uncontrolled systemic hypertension
  5. Participated in an investigational drug or device study within 90 days prior to signing consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02999906

Contacts
Contact: Robert Staszewski, MA 919-425-8190 rstaszewski@unither.com

Sponsors and Collaborators
United Therapeutics
  More Information

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT02999906     History of Changes
Other Study ID Numbers: TDE-PH-313
Study First Received: December 19, 2016
Last Updated: May 19, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by United Therapeutics:
PAH
Oral Treprostinil
dual therapy
6 Minute Walk Test

Additional relevant MeSH terms:
Tadalafil
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Treprostinil
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on June 22, 2017