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Trial record 24 of 66 for:    "Lung Disease" | "Bosentan"

First-line Bosentan and Sildenafil Combination Therapy for Pulmonary Arterial Hypertension

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ClinicalTrials.gov Identifier: NCT01247116
Recruitment Status : Completed
First Posted : November 24, 2010
Last Update Posted : June 12, 2018
Sponsor:
Collaborator:
Actelion
Information provided by (Responsible Party):
Naushad Hirani, University of Calgary

Tracking Information
First Submitted Date November 23, 2010
First Posted Date November 24, 2010
Last Update Posted Date June 12, 2018
Study Start Date December 2009
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 23, 2010)
6 minute walk test distance [ Time Frame: 4 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01247116 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 23, 2010)
  • 6 minute walk test distance [ Time Frame: 12 months ]
  • Echocardiographic parameters [ Time Frame: 4 months ]
  • Hemodynamics [ Time Frame: 4 months ]
  • Quality of Life as measured by CAMPHOR questionnaire [ Time Frame: 4 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title First-line Bosentan and Sildenafil Combination Therapy for Pulmonary Arterial Hypertension
Official Title First-line Bosentan and Sildenafil Combination Therapy for Pulmonary Arterial Hypertension: A Safety and Efficacy Pilot Study
Brief Summary The purpose of this study is to evaluate the strategy of initiating double oral combination therapy with bosentan and sildenafil at the time of diagnosis of pulmonary arterial hypertension (PAH) in a preliminary way.
Detailed Description

Current treatment paradigms for PAH suggest adopting goals of therapy with relatively objective parameters such as 6 minute walk distance to determine when to add a second oral agent (1). This often entails observing deterioration in the patient on a single agent before instituting the second one. This strategy could be problematic, as patients may never recover the function lost due to progressive PAH (2). In addition, given the malignant nature of the clinical course of PAH in many cases and the nature of the underlying proliferative vasculopathy, some have argued that altering this paradigm to resemble that used in cancer chemotherapy may be more appropriate (3). That is, "induction" therapy at diagnosis with multiple agents followed by a maintenance phase of treatment might offer significant benefits to the patient.

This open-label pilot study is the first to investigate the potential efficacy and safety of a first-line combination strategy in consecutive patients with PAH in contrast to the "add-on" strategy for combination therapy. It will serve as the basis on which to consider larger, multicenter investigations of this strategy.

  1. Hoeper M, et al. Eur Respir J. 2005 Nov;26(5):858-63.
  2. Halpern SD, et al. Proc Am Thorac Soc. 2008 Jul 15;5(5):631-5.
  3. Provencher S, et al. Chest. 2005 Dec;128(6 Suppl):622S-628S.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Consecutive patients with idiopathic pulmonary arterial hypertension (IPAH) or PAH associated with connective tissue disease that are naive to PAH targeted therapies will be enrolled.
Condition Hypertension, Pulmonary
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 9, 2018)
12
Original Estimated Enrollment
 (submitted: November 23, 2010)
15
Actual Study Completion Date December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with symptomatic Functional Class III PAH in the following categories: Idiopathic (IPAH), Familial (FPAH), Associated with connective tissue disease, Associated with drugs or toxins
  • PAH diagnosed by right heart catheterization, defined as: mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg, PVR > 3 mmHg/l/min (Wood units) or > 240 dyn sec cm-5, pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg
  • Baseline 6 MWT distance > 150 and < 450 m

Exclusion Criteria:

  • Treatment with ERAs other than bosentan;
  • Treatment with PDE5 inhibitors other than sildenafil;
  • Treatment with any prostanoid;
  • PAH associated with thyroid disorders, glycogen storage disease, Gaucher disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders and splenectomy; valvular disease with valvular lesions to be excluded by echocardiogram within 2 years prior to randomization
  • Restrictive lung disease: total lung capacity (TLC) < 60% of normal predicted value;
  • Obstructive lung disease: forced expiratory volume/forced vital capacity (FEV1/FVC) < 50%
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT01247116
Other Study ID Numbers BSC-UOC-2009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Naushad Hirani, University of Calgary
Study Sponsor University of Calgary
Collaborators Actelion
Investigators
Principal Investigator: Naushad Hirani, MD University of Calgary
PRS Account University of Calgary
Verification Date June 2018