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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
| United Therapeutics | INDUSTRY |
| University of Cincinnati | OTHER |
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This study is designed to assess safety and efficacy of tadalafil in patients with Sarcoidosis Associated Pulmonary Hypertension.
Hypothesis: Tadalafil is safe and effective in treating pulmonary hypertension in patients with Sarcoidosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sarcoid Associated Pulm. Hypertension | Experimental | Single-arm open-label proof of concept study of tadalafil in patients with sarcoidosis associated pulmonary hypertension. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tadalafil | Drug | 20mg/day for one month then 40mg/day for additional 4 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6 Minute Walk Distance | Baseline, Week 8, Week 16, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Resting Oxygen Saturation | Percent oxygen saturation of hemoglobin as measured by pulse oximetry in the resting state. | Baseline, Week 24 |
| Oxygen Desaturation During 6 Minute Walk Test | Change (decrease) in oxygen saturation from start of 6 minute walk to nadir during the 6 minute walk test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hubert J Ford, M.D. | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States | ||
| University of Cincinnati |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28090299 | Derived | Ford HJ, Baughman RP, Aris R, Engel P, Donohue JF. Tadalafil therapy for sarcoidosis-associated pulmonary hypertension. Pulm Circ. 2016 Dec;6(4):557-562. doi: 10.1086/688775. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tadalafil | 40 mg daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tadalafil | 40 mg daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 6 Minute Walk Distance | Only 6 of the 7 study completers performed 6 minute walk test through week 24 | Posted | Mean | Standard Deviation | meters | Baseline, Week 8, Week 16, Week 24 |
|
|
24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tadalafil | 40 mg daily | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
Since this was a proof of concept study evaluating safety and tolerability of the intervention in this population, it was not powered to achieve statistical significance in changes observed from baseline to week 24 in any of the endpoints.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| H. James Ford, MD | University of North Carolina at Chapel Hill | (919) 966-2531 | hjford@med.unc.edu |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000068581 | Tadalafil |
| ID | Term |
|---|---|
| D002243 | Carbolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Baseline, Week 24 |
| Maximum Borg Dyspnea Score During 6 Minute Walk Test | The modified Borg scale consists of a vertical scale labelled 0 to10 with corresponding verbal expressions of progressively increasing sensation (shortness of breath) intensity. 0 represents no dyspnea, and 10 is the highest level of perceived dyspnea. | Baseline, Week 8, Week 16, Week 24 |
| Brain Natriuretic Peptide Level | Baseline, Week 8, Week 16, Week 24 |
| Short Form-36 Global Score | SF- 36 investigates the standard of quality of life through a general health assessment and not specific to a particular disease, age or treatment group. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. The global score is determined by taking an average of the individual domain scores. The global score range is from 0 (worst) to 100 (best). | Baseline, Week 8, Week 16, Week 24 |
| St. George's Respiratory Questionnaire (SGRQ) Score | The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life) | Baseline, Week 8, Week 16, Week 24 |
| Number of Participants With Change in WHO Functional Class (WHO FC) | The WHO functional classification ranges from I (patient's disease does not affect daily activities) to IV (patient's disease causes severe impairment). Higher scores indicate more severe impairment. | Baseline, Week 24 |
| Cincinnati |
| Ohio |
| 45267 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| FEV1 | Mean | Standard Deviation | percent predicted |
|
| FVC | Mean | Standard Deviation | percent predicted |
|
| DLCO | Mean | Standard Deviation | percent predicted |
|
| Right Atrial Pressure | Mean | Standard Deviation | mm Hg |
|
| Mean Pulmonary Artery Pressure | Mean | Standard Deviation | mm Hg |
|
| Pulmonary Artery Wedge Pressure | Mean | Standard Deviation | mm Hg |
|
| Cardiac Index | Mean | Standard Deviation | L/min/m² |
|
| Pulmonary Vascular Resistance | Mean | Standard Deviation | Wood Units |
|
|
|
| Secondary | Resting Oxygen Saturation | Percent oxygen saturation of hemoglobin as measured by pulse oximetry in the resting state. | only 6 of the 7 study completers performed the 6 minute walk test through week 24. | Posted | Mean | Standard Deviation | percent | Baseline, Week 24 |
|
|
|
|
| Secondary | Oxygen Desaturation During 6 Minute Walk Test | Change (decrease) in oxygen saturation from start of 6 minute walk to nadir during the 6 minute walk test | Only 6 of the 7 study completers performed the 6 minute walk test through week 24 | Posted | Mean | Standard Deviation | oxygen saturation percentage points | Baseline, Week 24 |
|
|
|
|
| Secondary | Maximum Borg Dyspnea Score During 6 Minute Walk Test | The modified Borg scale consists of a vertical scale labelled 0 to10 with corresponding verbal expressions of progressively increasing sensation (shortness of breath) intensity. 0 represents no dyspnea, and 10 is the highest level of perceived dyspnea. | Only 6 of the 7 study completers performed 6 minute walk test through the end of the study. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 8, Week 16, Week 24 |
|
|
|
|
| Secondary | Brain Natriuretic Peptide Level | Posted | Mean | Standard Deviation | pg/mL | Baseline, Week 8, Week 16, Week 24 |
|
|
|
|
| Secondary | Short Form-36 Global Score | SF- 36 investigates the standard of quality of life through a general health assessment and not specific to a particular disease, age or treatment group. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. The global score is determined by taking an average of the individual domain scores. The global score range is from 0 (worst) to 100 (best). | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 8, Week 16, Week 24 |
|
|
|
|
| Secondary | St. George's Respiratory Questionnaire (SGRQ) Score | The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life) | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 8, Week 16, Week 24 |
|
|
|
|
| Secondary | Number of Participants With Change in WHO Functional Class (WHO FC) | The WHO functional classification ranges from I (patient's disease does not affect daily activities) to IV (patient's disease causes severe impairment). Higher scores indicate more severe impairment. | Posted | Number | participants | Baseline, Week 24 |
|
|
|
| 12 |
| 0 |
| 12 |
| 5 |
| 12 |
| Joint pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Herpes zoster | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Influenza/pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D002318 |
| Cardiovascular Diseases |
| D026121 |
| Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| Title | Measurements |
|---|---|
|
| Week 24 |
|
| Title | Measurements |
|---|---|
|
| Week 24 |
|
|
| Week 24 |
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