Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2006-001464-23 | EudraCT Number | ||
| PATHWAYS | Other Identifier | Alias Study Number |
Not provided
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To assess the efficacy and safety of sildenafil when added to patients with PAH who are taking bosentan as all or part of their background therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator |
| |
| Active | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bosentan | Drug | Bosentan + Placebo for 12 weeks of the study (double blind), then 12 months open label phase (bosentan + sildenafil) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Total Distance Walked During 6 Minute Walk Time (6MWT) at Week 12 | 6MWT is the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Week 12 LOCF | WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity) to Class IV (can not perform a physical activity without any symptoms, dyspnea at rest). Improvement=reduction in functional class; deterioration = increase in functional class, no change = no change in functional class. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Los Angeles VA Healthcare, Pulmonary Hypertension Program | Los Angeles | California | 90073 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28874133 | Derived | Vizza CD, Jansa P, Teal S, Dombi T, Zhou D. Sildenafil dosed concomitantly with bosentan for adult pulmonary arterial hypertension in a randomized controlled trial. BMC Cardiovasc Disord. 2017 Sep 6;17(1):239. doi: 10.1186/s12872-017-0674-3. |
Not provided
Not provided
Participants were on bosentan therapy for 3 months prior. Participants were randomized to sildenafil or placebo. Part A study was double-blind phase (12 weeks) and Part B was 12 months open-label phase. 53 and 51 participants were randomized to placebo and sildenafil arm respectively. One participant in sildenafil arm did not receive any treatment
This study was conducted at 29 active centers in 10 countries (10 centers in Germany, 5 centers in the United States of America [USA], 3 centers in France, 2 centers in Australia, Czech Republic, Italy, and Israel, and 1 center in Greece, Taiwan and United Kingdom [UK])
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study. In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part A (Double Blind Randomized) |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Bosentan + Placebo for 12 weeks of the study (double blind), then 12 months open label phase (bosentan + sildenafil) |
|
| Bosentan | Drug | Bosentan + Sildenafil for 12 weeks of the study (double blind), then 12 months open label phase |
|
| Sildenafil Citrate | Drug | Bosentan + Sildenafil for 12 weeks of the study (double blind), then 12 months open label phase |
|
| Week 12 |
| Clinical Worsening Events | No survival analysis was carried out for the study due to very few events of clinical worsening. Hence, we present a summary of clinical worsening events instead. Events of clinical worsening were categorized as (A). Death, (B). Heart/lung transplantation, (C). Hospitalization due to pulmonary arterial hypertension (PAH), and (D). Clinical deterioration of PAH requiring additional therapy. | Week 12 |
| Change From Baseline in Borg Dyspnea Score at Week 12 | Borg dyspnea scale is a 10-point scale where following scores stands for severity of dyspnea: 0 (no breathlessness at all); 0.5 (very very slight [just noticeable]);
5 (severe breathlessness); 7 (very severe breathlessness); 9 (very very severe [almost maximum]); and 10 (maximum). | Week 12 |
| One Year Survival Probability From the Start of Sildenafil Treatment. | The survival probability of all participants up to 1-year post start of Sildenafil treatment; for participants who were randomized to Sildenafil, this was the week 52 from randomization, and for participants who were originally randomized to Placebo group, this was the Week 64 from Baseline (Week 52 from Week 12, when the first dose of Sildenafil was administered to these participants). Those participants who discontinued from the study prior to 1 year after start of sildenafil were considered as censored at the time of discontinuation and those who discontinued from the study post 1-year after start of sildenafil were considered as censored at the time of 1-year post start of sildenafil. | One year from the time of starting sildenafil |
| One Year Survival From the Start of Sildenafil Treatment. | The survival status of all participants who discontinued from the study, including those participants who discontinued during the double-blind phase, was to be assessed at one year post their Week 12 visit/ End of treatment visit. | One year from the time of starting sildenafil |
| Henry Ford Hospital |
| Detroit |
| Michigan |
| 48202 |
| United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| Diagnostics Research Group | San Antonio | Texas | 78229 | United States |
| St. Vincents Hospital | Darlinghurst | New South Wales | 2010 | Australia |
| The Prince Charles Hospital | Chermside | Queensland | 4032 | Australia |
| Vseobecna fakultni nemocnice v Praze | Prague | 128 08 | Czechia |
| Institut klinicke a experimentalni mediciny, Klinika kardiologie | Prague | 140 21 | Czechia |
| Clinique des Maladies Respiratoires | Lille | 59037 | France |
| Hopital Claude Huriez | Lille | 59037 | France |
| Hopital Adules Brabois | Vandœuvre-lès-Nancy | 54511 | France |
| Unfallkrankenhaus Berlin, Klinik fuer Innere Medizin | Berlin | 12683 | Germany |
| II. Medizinische Klinik, Kardiologie, Angiologie und Pneumologie | Coburg | 96450 | Germany |
| Universitaetsklinikum Essen, Zentrum fuer Innere Medizin, Klinik fuer Kardiologie | Essen | 45122 | Germany |
| Universitaetsklinikum Giessen und Marburg GmbH, Standort Giessen | Giessen | 35392 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Universitaetsklinikum des Saarlandes, Innere Medizin V | Homburg | 66421 | Germany |
| Medizinische Klinik und Poliklinik I, Universitaetsklinikum Leipzig | Leipzig | 04103 | Germany |
| Med. Klinik u. Poliklinik I der LMU Muenchen, Klinikum Grosshadern | München | 81377 | Germany |
| Praxis fuer Innere Medizin, Kardiologie und Angiologie | Nuremberg | 90402 | Germany |
| Missionsaerztliche Klinik Wuerzburg, Gemeinnuetzige Gesellschaft mbH | Würzburg | 97067 | Germany |
| Attikon Hospital | Haidari | Athens | 12462 | Greece |
| Rambam Medical Center | Haifa | 31096 | Israel |
| Rabin Medical Centre | Petah Tikva | 49100 | Israel |
| Cardiologia, Azienda Ospedaliera Monaldi, Seconda Università di Napoli | Naples | 80131 | Italy |
| Unita' di Ipertensione Polmonare, Dipartimento di Scienze Respiratorie e Cardiovascolari | Roma | 00161 | Italy |
| Department of Surgery, National Taiwan University Hospital | Taipei | 100 | Taiwan |
| PVDU | Papworth Everard | Cambridgeshire | CB23 3RE | United Kingdom |
| FG001 |
| Sildenafil |
In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study. In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Part B (Open-label) |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study. In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months |
| BG001 | Sildenafil | In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study. In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Six Minute Walk Test (6MWT) | 6MWT is the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety. | Mean | Standard Deviation | Meters |
| ||||||||||||||
| Mean Pulmonary Artery Pressure (mPAP) | Mean | Standard Deviation | Millimeter(mm) of mercury(Hg) |
| |||||||||||||||
| World Health Organization Functional Class in Participants with Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension criteria for WHO Class: Class I (Participants with no limitation of physical activity); Class II (Participants with slight limitation of physical activity); Class III (Participants with marked limitation of physical activity); Class IV (Participants with inability to carry out any physical activity). | Number | Participants |
|
| 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 | Change From Baseline in the Total Distance Walked During 6 Minute Walk Time (6MWT) at Week 12 | 6MWT is the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety. | Intent-to-Treat (ITT) Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication. Missing values were replaced according to the last observation carried forward (LOCF) approach. Statistical analysis was carried out on LOCF values. | Posted | Mean | Standard Deviation | Meters | Week 12 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Week 12 LOCF | WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity) to Class IV (can not perform a physical activity without any symptoms, dyspnea at rest). Improvement=reduction in functional class; deterioration = increase in functional class, no change = no change in functional class. | ITT Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication. Missing values were replaced according to the LOCF approach. | Posted | Number | Participants | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Worsening Events | No survival analysis was carried out for the study due to very few events of clinical worsening. Hence, we present a summary of clinical worsening events instead. Events of clinical worsening were categorized as (A). Death, (B). Heart/lung transplantation, (C). Hospitalization due to pulmonary arterial hypertension (PAH), and (D). Clinical deterioration of PAH requiring additional therapy. | ITT Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication. | Posted | Number | Participants | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Borg Dyspnea Score at Week 12 | Borg dyspnea scale is a 10-point scale where following scores stands for severity of dyspnea: 0 (no breathlessness at all); 0.5 (very very slight [just noticeable]);
5 (severe breathlessness); 7 (very severe breathlessness); 9 (very very severe [almost maximum]); and 10 (maximum). | ITT Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication. Missing values were replaced according to the last observation carried forward LOCF approach. | Posted | Mean | Standard Deviation | Units on a scale | Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | One Year Survival Probability From the Start of Sildenafil Treatment. | The survival probability of all participants up to 1-year post start of Sildenafil treatment; for participants who were randomized to Sildenafil, this was the week 52 from randomization, and for participants who were originally randomized to Placebo group, this was the Week 64 from Baseline (Week 52 from Week 12, when the first dose of Sildenafil was administered to these participants). Those participants who discontinued from the study prior to 1 year after start of sildenafil were considered as censored at the time of discontinuation and those who discontinued from the study post 1-year after start of sildenafil were considered as censored at the time of 1-year post start of sildenafil. | ITT Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication. Missing values were replaced according to the last observation carried forward LOCF approach. The participants in placebo arm have received Sildenafil on or after Week 12. | Posted | Number | 90% Confidence Interval | Probability of death | One year from the time of starting sildenafil |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | One Year Survival From the Start of Sildenafil Treatment. | The survival status of all participants who discontinued from the study, including those participants who discontinued during the double-blind phase, was to be assessed at one year post their Week 12 visit/ End of treatment visit. | ITT Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication. Missing values were replaced according to the last observation carried forward LOCF approach. The participants in placebo arm have received Sildenafil on or after Week 12. | Posted | Number | Participants who died | One year from the time of starting sildenafil |
|
From the time that the participant provides informed consent through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study. In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months. | 23 | 53 | 38 | 53 | ||
| EG001 | Sildenafil | In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study. In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months. | 22 | 50 | 33 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Contrast media allergy | Immune system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Gastritis viral | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Paresis | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cardiovascular disorder | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Walking distance test abnormal | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Skin graft | Surgical and medical procedures | MedDRA 15.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077300 | Bosentan |
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Withdrawal by Subject |
|
| Lack of Efficacy |
|
| Adverse Event |
|
| Protocol Violation |
|
| Male |
|
| Class II |
|
| Class III |
|
| Class IV |
|
| Superiority or Other (legacy) |
|
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| Units | Counts |
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| Participants |
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| Sildenafil |
In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study. In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months. |
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