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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00780728
Recruitment Status : Withdrawn
First Posted : October 28, 2008
Last Update Posted : November 13, 2009
Information provided by:
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Hypertension, Pulmonary Drug: Sildenafil Phase 3

Study Type : Interventional  (Clinical Trial)
Official Title: Addition of Sildenafil to Bosentan Monotherapy in Patients With Pulmonary Arterial Hypertension (PAH)

Arm Intervention/treatment
Active Comparator: Sildenafil Drug: Sildenafil

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Inclusion & Exclusion Criteria Identifier: NCT00780728     History of Changes
Other Study ID Numbers: UHNOHI
First Posted: October 28, 2008    Key Record Dates
Last Update Posted: November 13, 2009
Last Verified: November 2009

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