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| Sponsor: | United Therapeutics |
|---|---|
| Collaborators: |
National Institutes of Health (NIH) National Heart, Lung, and Blood Institute (NHLBI) Eli Lilly and Company Johns Hopkins University |
| Information provided by: | United Therapeutics |
| ClinicalTrials.gov Identifier: | NCT01042158 |
Purpose
This will be a 36-week, randomized, double-blind, parallel group study comparing the effects of tadalafil monotherapy, ambrisentan monotherapy and combination therapy with tadalafil and ambrisentan in patients with PAH-SSc. Standard outcome measures such as six-minute walk distance (6MWD), NYHA classification, and hemodynamic measurements will be assessed, as well as novel functional measures of RV-PV function including the transthoracic echocardiogram parameter tricuspid annular plane systolic ejection (TAPSE), contrast-enhanced cardiac MRI and heart rate variability assessed by Holter monitoring. This design (excluding a placebo-placebo arm) was selected for ethical concerns and to provide optimal efficiency and active therapy to all study subjects. It also allows for comparisons between the two monotherapies and with combination therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Arterial Hypertension Systemic Sclerosis Scleroderma Spectrum of Diseases Connective Tissue Disease Pulmonary Hypertension |
Drug: Tadalafil monotherapy Drug: Ambrisentan monotherapy Drug: tadalafil and ambrisentan |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis |
| Estimated Enrollment: | 63 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Tadalafil monotherapy |
Drug: Tadalafil monotherapy
tadalafil 20 mg once daily (qd) and placebo qd. Up-titration of study medications will occur at week 4 (tadalafil 40 mg qd). If a subject experiences an intolerable adverse event as a result of an uptitration in the study drug dose, the dose of study drug maybe down titrated to 20 mg of tadalafil. If the subject is still experiencing an intolerable adverse event, then the investigator will withdraw the subject from the study.
Other Name: Adcirca
|
| Active Comparator: Ambrisentan monotherapy |
Drug: Ambrisentan monotherapy
ambrisentan 5 mgs daily and placebo qd. Up-titration of study medications will occur at week 4 (ambrisentan 10 mgs daily). If a subject experiences an intolerable adverse event as a result of an uptitration in the study drug dose, the dose of study drug maybe down titrated to 5mg of ambrisentan. If the subject is still experiencing an intolerable adverse event, then the investigator will withdraw the subject from the study.
Other Name: Letairis
|
| Active Comparator: Tadalafil and ambrisentan |
Drug: tadalafil and ambrisentan
tadalafil 20 mg qd and ambrisentan 5 mg qd. Up-titration of study medications will occur at week 4 (ambrisentan 10 mgs daily and tadalafil 40 mg qd). If a subject experiences an intolerable adverse event as a result of an uptitration in the study drug dose, the dose of study drug maybe down titrated to 20 mg of tadalafil and/or 5mg of ambrisentan. If the subject is still experiencing an intolerable adverse event, then the investigator will withdraw the subject from the study.
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Interstitial lung disease
Contacts and Locations| Contact: Paul Hassoun, MD | 410-614-5158 | phassoun@jhmi.edu |
| Contact: Sukhminder Singh | 410-614-1316 | ssingh30@jhmi.edu |
| United States, Maryland | |
| Johns Hopkins University | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Sukhminder Sukhminder 410-614-5158 ssingh30@jhmi.edu | |
| Principal Investigator: Paul Hassoun, MD | |
| Sub-Investigator: Reda Girgis, MD | |
| Sub-Investigator: Stephen Mathai, MD | |
| Sub-Investigator: Fredrick Wigley, MD | |
| Sub-Investigator: Ari Zaiman, MD | |
| Principal Investigator: | Paul Hassoun, MD | Johns Hopkins University |
More Information
| Responsible Party: | Paul Hassoun, MD, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT01042158 History of Changes |
| Other Study ID Numbers: | TAD-PH-001, P50HL084946 |
| Study First Received: | January 4, 2010 |
| Last Updated: | January 4, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Tadalafil Ambrisentan Quality of Life |
|
Hypertension, Pulmonary Connective Tissue Diseases Scleroderma, Systemic Scleroderma, Diffuse Hypertension Sclerosis Lung Diseases Respiratory Tract Diseases Skin Diseases Vascular Diseases Cardiovascular Diseases |
Pathologic Processes Tadalafil Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Vasodilator Agents Cardiovascular Agents Therapeutic Uses |