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Tests treatment safety and results for Idiopathic Pulmonary Hypertension
Official title Efficacy and Safety of Qishen Yiqi Dropping Pills in Patients With Severe Pulmonary Hypertension
ClinicalTrials.gov ID: NCT07604805
What this study is testing
What is Qishen Yiqi Dropping Pills 0.5g Oral Three Times Daily + Targeted Therapy for Pulmonary Arterial Hypertension?
Qishen Yiqi Dropping Pills 0.5g Oral Three Times Daily + Targeted Therapy for Pulmonary Arterial Hypertension is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for idiopathic pulmonary hypertension.
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 study aims to compare the effectiveness and safety of two treatment approaches for patients with severe pulmonary hypertension: standard targeted drug therapy alone, and a combination of standard targeted drugs plus Qishen Yiqi Dropping Pills over 52 weeks of treatment. Pulmonary hypertension is a chronic condition that raises blood pressure in the lung arteries, causing symptoms like shortness of breath, tiredness, and difficulty with physical activity.
- Time commitment: about 52 weeks
- 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 75
You may be able to join if
- 1\. Male or female participants aged between 18 and 75 years (inclusive) at the screening visit. 2\. Diagnosed with pulmonary arterial hypertension...
- Subgroup Ⅰ: Idiopathic pulmonary arterial hypertension (IPAH) under the category of arterial pulmonary hypertension
- Subgroup Ⅱ: Pulmonary hypertension secondary to left heart disease (congenital heart disease) 3. World Health Organization (WHO) Functional Class III...
You likely can't join if
- 1\. Meet any of the following criteria: 2. Diagnosed with Group 3 or Group 5 pulmonary hypertension (PH) according to the \ 2021 Chinese Guidelines...
- Body mass index (BMI) ≥ 30 kg/m² at screening visit
- History of essential hypertension
- Diabetes mellitus of any type
- History of significant coronary artery disease (CAD) confirmed by any of the following:
- History of myocardial infarction
See the full eligibility criteria
- 1\. Male or female participants aged between 18 and 75 years (inclusive) at the screening visit. 2\. Diagnosed with pulmonary arterial hypertension (PAH) classified according to the \ 2021 Chinese Guidelines for the...
- Subgroup Ⅰ: Idiopathic pulmonary arterial hypertension (IPAH) under the category of arterial pulmonary hypertension
- Subgroup Ⅱ: Pulmonary hypertension secondary to left heart disease (congenital heart disease) 3. World Health Organization (WHO) Functional Class III or IV symptoms at screening. 4\. Meet all of the following...
- 1\. Meet any of the following criteria: 2. Diagnosed with Group 3 or Group 5 pulmonary hypertension (PH) according to the \ 2021 Chinese Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension\ . 3\...
- Body mass index (BMI) ≥ 30 kg/m² at screening visit
- History of essential hypertension
- Diabetes mellitus of any type
- History of significant coronary artery disease (CAD) confirmed by any of the following:
- History of myocardial infarction
- History of percutaneous coronary intervention (PCI)
- Angiographic evidence of ≥ 50% stenosis in at least one major coronary artery
- Positive cardiac stress imaging test
- History of coronary artery bypass graft surgery (CABG)
- History of chronic stable angina or unstable angina 5. Uncontrolled systemic arterial hypertension: systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg at randomization visit (Day 1). 6\. History...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guagdong, 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 study runs about 52 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guagdong, 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.