- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00780728
Study Evaluating the Addition of Sildenafil to Bosentan Therapy in Pulmonary Arterial Hypertension
November 12, 2009 updated by: University Health Network, Toronto
Addition of Sildenafil to Bosentan Monotherapy in Patients With Pulmonary Arterial Hypertension (PAH)
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.
Study Overview
Study Type
Interventional
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion & Exclusion Criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Sildenafil
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
October 27, 2008
First Submitted That Met QC Criteria
October 27, 2008
First Posted (Estimate)
October 28, 2008
Study Record Updates
Last Update Posted (Estimate)
November 13, 2009
Last Update Submitted That Met QC Criteria
November 12, 2009
Last Verified
November 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Hypertension
- Pulmonary Arterial Hypertension
- Hypertension, Pulmonary
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Urological Agents
- Enzyme Inhibitors
- Phosphodiesterase Inhibitors
- Phosphodiesterase 5 Inhibitors
- Sildenafil Citrate
Other Study ID Numbers
- UHNOHI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertension, Pulmonary
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompletedIdiopathic Pulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited Kingdom
-
Centre Chirurgical Marie LannelongueUnknownChronic Thrombo-embolic Pulmonary Hypertension and Pulmonary Arterial HypertensionFrance
-
Heidelberg UniversityMerck Sharp & Dohme LLCRecruitingChronic Thromboembolic Pulmonary Hypertension | Primary Pulmonary Arterial HypertensionGermany
-
University of South FloridaWithdrawnPulmonary Arterial Hypertension | Familial Primary Pulmonary Hypertension | Idiopathic Pulmonary Arterial Hypertension | Primary Pulmonary HypertensionUnited States
-
BayerCompletedPrimary HypertensionChina
-
University of Kansas Medical CenterRecruitingPulmonary Arterial Hypertension | Pulmonary Hypertension | Chronic Thromboembolic Pulmonary Hypertension | Pulmonary Hypertension Due to Left Heart Disease | Pulmonary Hypertension, Primary, 4 | Pulmonary Hypertension, Primary, 2 | Pulmonary Hypertension, Primary, 3 | Pulmonary Hypertension, Primary and other conditionsUnited States
-
Vanderbilt University Medical CenterJohns Hopkins UniversityCompletedPulmonary Arterial Hypertension | Idiopathic Pulmonary Arterial Hypertension | Associated Pulmonary Arterial Hypertension | Heritable Pulmonary Arterial HypertensionUnited States
-
Papworth Hospital NHS Foundation TrustMerck Sharp & Dohme LLCCompleted
-
University of ZurichCompletedPulmonary Hypertension | Pulmonary Artery Hypertension | Chronic Thromboembolic Pulmonary HypertensionSwitzerland
-
National Taiwan University HospitalUnknownPulmonary HypertensionTaiwan
Clinical Trials on Sildenafil
-
University of PennsylvaniaWalter Reed National Military Medical CenterRecruiting
-
Rambam Health Care CampusUnknown
-
Duke UniversityNational Heart, Lung, and Blood Institute (NHLBI); PfizerCompleted
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedErectile DysfunctionSingapore
-
Northwestern UniversityCompletedHand Foot Skin ReactionUnited States
-
The Cleveland ClinicCompletedPulmonary Hypertension | Diffuse Parenchymal Lung DiseaseUnited States
-
Pfizer's Upjohn has merged with Mylan to form Viatris...Completed
-
iX Biopharma Ltd.Linear Clinical ResearchCompletedErectile DysfunctionAustralia
-
Rigshospitalet, DenmarkGlostrup University Hospital, CopenhagenCompletedBecker Muscular DystrophyDenmark
-
N4 Pharma UK Ltd.BDD Pharma LtdCompleted