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Study Evaluating the Addition of Sildenafil to Bosentan Therapy in Pulmonary Arterial Hypertension

Primary Purpose

Hypertension, Pulmonary

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Sildenafil
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Hypertension, Pulmonary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes
Inclusion & Exclusion Criteria

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Active Comparator

    Arm Label

    Sildenafil

    Arm Description

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 27, 2008
    Last Updated
    November 12, 2009
    Sponsor
    University Health Network, Toronto
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00780728
    Brief Title
    Study Evaluating the Addition of Sildenafil to Bosentan Therapy in Pulmonary Arterial Hypertension
    Official Title
    Addition of Sildenafil to Bosentan Monotherapy in Patients With Pulmonary Arterial Hypertension (PAH)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2009
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University Health Network, Toronto

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will examine the effects of add-on sildenafil to bosentan monotherapy in patients with Pulmonary Arterial Hypertension. Patients on bosentan monotherapy will be followed every 6 months to assess if they have met the pre-defined treatment goals. If a patient fails to achieve these treatment goals or fails to maintain them, sildenafil will be added to their existing bosentan monotherapy. Patients will be assessed 6 months after start of combination therapy for changes in 6MWT, Borg dyspnea scale, WHO functional class, quality of life.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension, Pulmonary

    7. Study Design

    Study Phase
    Phase 3

    8. Arms, Groups, and Interventions

    Arm Title
    Sildenafil
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Sildenafil

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion & Exclusion Criteria

    12. IPD Sharing Statement

    Learn more about this trial

    Study Evaluating the Addition of Sildenafil to Bosentan Therapy in Pulmonary Arterial Hypertension

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