BridgeMD
New treatment option for Pulmonary Arterial Hypertension (PAH)
Official title Comparison of Sequential to Initial Combination Therapy in PAH
ClinicalTrials.gov ID: NCT06968962
What this study is testing
What is Tadalafil?
Tadalafil is an investigational medicine, being studied as a potential treatment for pulmonary arterial hypertension (pah).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multicenter, randomized, controlled, double-blind, and non-inferiority clinical trial to compare the efficacy of sequential to initial combination therapy in patients with pulmonary arterial hypertension (PAH). Ambrisentan and Tadalafil will be used in the study.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age between 18 to 80 years and weight ≥ 40 kg.
- WHO functional classification I-III.
- Diagnosed with PAH caused or related to the following: 1) Idiopathic PAH 2) Hereditary PAH 3) Associated PAH:
- Connective tissue diseases (e.g., scleroderma, systemic lupus erythematosus, mixed connective tissue disease, etc.)
- Drug or toxin exposure
You likely can't join if
- 1\. Other types of pulmonary arterial hypertension (PAH)
- Other types of PAH, such as HIV-related PAH, schistosomiasis-related PAH, etc.
- Pulmonary arterial hypertension associated with portal hypertension
- Pulmonary vein occlusive disease or pulmonary capillary hemangiomatosis 2. Group 4 PH, e.g. Chronic thromboembolic pulmonary hypertension 3. Group 2...
- people who have received intravenous inotropes (e.g., dobutamine) within 2 weeks prior to the screening visit.
- people receiving protease inhibitors, systemic ketoconazole, or systemic itraconazole therapy.
See the full eligibility criteria
- Age between 18 to 80 years and weight ≥ 40 kg.
- WHO functional classification I-III.
- Diagnosed with PAH caused or related to the following: 1) Idiopathic PAH 2) Hereditary PAH 3) Associated PAH:
- Connective tissue diseases (e.g., scleroderma, systemic lupus erythematosus, mixed connective tissue disease, etc.)
- Drug or toxin exposure
- Corrected congenital heart diseases for more than 1 year (e.g., atrial septal defect, ventricular septal defect, and patent ductus arteriosus) 4. Risk stratification assessed as low-risk or intermediate-risk according...
- 1\. Other types of pulmonary arterial hypertension (PAH)
- Other types of PAH, such as HIV-related PAH, schistosomiasis-related PAH, etc.
- Pulmonary arterial hypertension associated with portal hypertension
- Pulmonary vein occlusive disease or pulmonary capillary hemangiomatosis 2. Group 4 PH, e.g. Chronic thromboembolic pulmonary hypertension 3. Group 2 PH, i.e., PH associated with left heart disease 4. Group 3 PH, i.e...
- people who have received intravenous inotropes (e.g., dobutamine) within 2 weeks prior to the screening visit.
- people receiving protease inhibitors, systemic ketoconazole, or systemic itraconazole therapy.
- people receiving strong CYP3A4 inducers (e.g., rifampicin).
- people who have received unstable doses of calcium channel blockers or HMG-CoA reductase inhibitors (statins) within 4 weeks prior to the screening visit (eligible people must not have changed doses within 4 weeks prior...
- people with a history of angina or who have received long-acting or short-acting nitrate treatment within the 12 weeks prior to the visit. 8\. Laboratory Tests at Screening 1） Serum ALT or AST laboratory values \> 2...
- Severe liver dysfunction (Child-Pugh Class C, with or without cirrhosis) at screening.
- Significant anemia in the opinion of the investigator.
- History of bleeding disorders or significant active peptic ulcers.
- Uncontrolled hypertension (≥ 180/110 mmHg) at screening.
- Severe hypotension (\< 90/50 mmHg) at screening.
- Myocardial infarction within 3 months prior to screening.
- Clinically significant aortic or mitral valve disease, constrictive pericarditis, restrictive or congestive cardiomyopathy, life-threatening arrhythmias, significant left ventricular dysfunction, left ventricular...
- History of non-arteritic anterior ischemic optic neuropathy.
- Hereditary degenerative retinal disease (e.g., retinitis pigmentosa).
- Significant fluid retention in the opinion of the investigator.
- people with cardiovascular, liver, kidney, hematologic, gastrointestinal, immune, endocrine, metabolic, or central nervous system diseases that the investigator believes may adversely affect the subject's safety and/or...
- History of malignant tumors within the past 5 years, except for those with local, non-metastatic basal cell carcinoma, cervical carcinoma in situ, or prostate cancer who are not anticipated to receive radiotherapy...
- Pregnant or breastfeeding female people.
- people with demonstrated poor compliance.
- History of alcohol abuse or illicit drug use within 1 year.
- Participation in clinical studies involving another investigational drug or device within 4 weeks prior to the screening visit. people who fail inclusion/exclusion criteria may be re-screened once.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.