Trials Sponsors Conditions Drugs Pricing

Conditions

Connective Tissue Disease Pulmonary Arterial Hypertension Pulmonary Hypertension Scleroderma Spectrum of Diseases Systemic Sclerosis

Keywords

TadalafilAmbrisentanQuality of Life

Outcome Measures

Primary Outcomes (2)

Right Ventricular (RV) Mass
Assessment of change in Right ventricular mass was done via standard volumetric cine images of the right heart at baseline and comparing it to that at the end of 36 weeks using Cardiac Magnetic Resonance Imaging studies.
baseline and 36 weeks
Pulmonary Vascular Resistance (PVR)
Change in Pulmonary Vascular Resistance (PVR) was ascertained via Right Heart Catheterization (RHC) measurement of the difference between the PVR at baseline and 36 weeks
baseline 36 weeks

Secondary Outcomes (2)

Tricuspid Annular Plane Systolic Excursion (TAPSE)
baseline and 36 weeks

Study Arms (1)

Tadalafil and ambrisentan upfront therapy

OTHER

This will be a 36-week, single group, open label study assessing the effects of Tadalafil plus Ambrisentan combination therapy in patients with pulmonary arterial hypertension associated with the scleroderma spectrum of disease (PAH-SSD).

Drug: tadalafil and ambrisentan upfront combination therapy

Interventions

tadalafil and ambrisentan upfront combination therapyDrug

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.

Also known as: Adcirca, Letairis

Tadalafil and ambrisentan upfront therapy

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
tadalafil and ambrisentan upfront combination therapy
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

A right heart catheterization done at baseline with a mean pulmonary artery pressure (mPAP) ≥ 25mmHg, pulmonary artery wedge pressure (PAWP) ≤ 15mmHg, and pulmonary vascular resistance (PVR) ≥3 Woods units.
Scleroderma defined as systemic sclerosis with diffuse or limited scleroderma meeting the American College of Rheumatology (ACR) criteria (33). Cases will be included if they meet clinical features that satisfy ACR criteria for a diagnosis of scleroderma or the presence of three of five features of the CREST syndrome are identified; or there is the presence of definite Raynaud's phenomenon, abnormal nail fold capillaries typical of scleroderma and the presence of a specific scleroderma related auto-antibody. Limited skin involvement is defined as skin tightening distal to elbows and knees with or without facial involvement; and diffuse skin involvement, tightening proximal to these joints or truncal involvement.

Sponsors & Collaborators

Stanford University
Othercollaborator
National Heart, Lung, and Blood Institute (NHLBI)
NIHcollaborator
University of Texas

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Related Publications (2)

Sato T, Ambale-Venkatesh B, Lima JAC, Zimmerman SL, Tedford RJ, Fujii T, Hulme OL, Pullins EH, Corona-Villalobos CP, Zamanian RT, Minai OA, Girgis RE, Chin K, Khair R, Damico RL, Kolb TM, Mathai SC, Hassoun PM. The impact of ambrisentan and tadalafil upfront combination therapy on cardiac function in scleroderma associated pulmonary arterial hypertension patients: cardiac magnetic resonance feature tracking study. Pulm Circ. 2018 Jan-Mar;8(1):2045893217748307. doi: 10.1177/2045893217748307. Epub 2017 Dec 18.
PMID: 29251556DERIVED
Hassoun PM, Zamanian RT, Damico R, Lechtzin N, Khair R, Kolb TM, Tedford RJ, Hulme OL, Housten T, Pisanello C, Sato T, Pullins EH, Corona-Villalobos CP, Zimmerman SL, Gashouta MA, Minai OA, Torres F, Girgis RE, Chin K, Mathai SC. Ambrisentan and Tadalafil Up-front Combination Therapy in Scleroderma-associated Pulmonary Arterial Hypertension. Am J Respir Crit Care Med. 2015 Nov 1;192(9):1102-10. doi: 10.1164/rccm.201507-1398OC.
PMID: 26360334

MeSH Terms

Conditions

Pulmonary Arterial HypertensionScleroderma, SystemicConnective Tissue DiseasesHypertension, Pulmonary

Interventions

Tadalafilambrisentan

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesSkin and Connective Tissue DiseasesSkin DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Limitations and Caveats

1. An open-label study with no placebo group 2. Relatively small number of patients and therefore vulnerable to confounding natural history with treatment effects 3. Measurements performed at four different institutions 4. Few missing data

Results Point of Contact

Title: Paul Hassoun, MD
Organization: Johns Hopkins University

Study Officials

Paul Hassoun, MD
Johns Hopkins University
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

25 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 4, 2010

First Posted

January 5, 2010

Study Start

January 2010

Date type not reported

This date has not been verified as actual or estimated.

A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (1)

Tadalafil and ambrisentan upfront therapy

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (1)

Tadalafil and ambrisentan upfront therapy

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations