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Pulmonary Arterial HypertensionPhase 3AMBLENCT05437224

Efficacy and Safety Study of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension

A Phase 3 study testing Ambrisentan in people with Pulmonary Arterial Hypertension, run by RenJi Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This multicenter, open label, single-arm study is aim at investigating the the efficacy and safety of china made ambrisentan in Chinese subjects with PAH. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pulmonary Arterial Hypertension
What is being tested?
Ambrisentan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
18 Dec 2018to 6 Feb 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years old and ≤75 years old, regardless of gender;
  • patients weighing ≥ 40 kg;
  • Patients diagnosed with PAH in Group 1 of the WHO Updated Clinical Classification of Pulmonary Hypertension (WHO functional class II or III);
  • 6 min walk test (6MWT), walking distance ≥ 50 m;
  • Right heart catheterization performed within 6 months prior to screening and meeting the following hemodynamic criteria:
  • mean pulmonary artery pressure ≥ 25 mm Hg；
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  • Pulmonary vascular resistance ≥ 240 dyn·s·cm-5;
  • Pulmonary artery wedge pressure or left ventricular end-diastolic pressure ≤ 15 mmHg;
  • Subject receiving calcium channel blocker (CCB) drugs, only those whose doses have been stabilized for more than 4 weeks at the time of screening are allowed to be included in the study;
  • Pulmonary function testing performed within 6 months prior to screening and meeting the following criteria：
  • Total lung capacity ≥ 60% of normal predicted value;
  • Forced expiratory volume in one second (FEV1) ≥ 55% of normal expected value;
  • Female subjects of childbearing potential must have a negative pregnancy test at the Screening Visit and Day 0;
  • Females subjects of childbearing potential must use a medically acceptable method of contraception (eg, hormone therapy, IUD, barrier methods such as condoms or cervical caps) during the study;
  • Sign written informed consent

Who cannot join

  • Patients diagnosed with WHO updated PH clinical classification of group 2, 3, 4, 5;
  • Endothelin receptor antagonist therapy (eg, bosentan) has been discontinued prior to enrollment due to safety or tolerability concerns (non-drug-induced liver function abnormalities);
  • Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 2 times ULN;
  • Serum bilirubin level > 1.5 times ULN;
  • severe hepatic insufficiency (Child-Pugh class C);
  • severe renal insufficiency (creatinine clearance <30 mL/min);
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  • Hemoglobin concentration < 10 g/dL or hematocrit < 30%;
  • Contraindications to treatment identified by laboratory tests, physical examination, medical history, or other investigations
  • severe hypotension (diastolic < 50 mm Hg or systolic < 90 mm Hg);
  • Clinically significant aortic or mitral valve disease, pericardial constriction, restrictive or congestive cardiomyopathy, fatal arrhythmias, LV ejection fraction < 45%, LV outflow tract obstruction, symptomatic coronary heart disease, spontaneously low blood pressure;
  • A history of malignancy within 5 years prior to enrollment, except for basal cell carcinoma of the skin and carcinoma in situ of the cervix;
  • Subject taking endothelin receptor antagonists such as ambrisentan, bosentan and macitentan within 4 weeks prior to enrollment;
  • pregnant and lactating women;
  • Subject deemed unsuitable for participation in this study by other investigators

Trial locations and contacts

1 site in 1 country.

China1 site

  • Renji Hospital

    Shanghai, 200127

Other trials in China

About this study

Official title: A Multicenter Open Label Study to Evaluate Efficacy and Safety of China Made Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension

This multicenter, open label, single-arm study is aim at investigating the the efficacy and safety of china made ambrisentan in Chinese subjects with PAH.

Read the detailed description

Pulmonary arterial hypertension is a hemodynamic and pathophysiological state, which can cause progressive hyperplasia of pulmonary vascular walls and elevated pulmonary arterial pressure for various reasons. Ambrisentan is a selective endothelin-A (ETA) receptor antagonist with vasodilatory, antiproliferative and vascular remodeling effects at a dose of 5 mg or 10 mg once daily, oral. A number of international clinical studies have shown that ambrisentan can improve the hemodynamic parameters, WHO functional classification and exercise tolerance of PAH patients, and improve the survival rate. The domestic Ambrisentan tablet is produced by Jiangsu Hansoh Pharmaceutical Group Co., Ltd. under the trade name of "Pu Nuo An". It has been developed and completed according to the consistency evaluation standard after the bioequivalence test, and is currently listed in mainland China. In view of the low price of the domestic ambrisentan, in order to verify its efficacy and safety in the real world, this post-marketing multicenter clinical study was carried out.

Being tested
Ambrisentan
Keywords
PAH, ambrisentan
Medical subject headings
Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmbrisentanDrug

    eligible subjects received 5 mg ambrisentan orally once daily for a 12-week primary evaluation period. Subjects then proceeded to a 12-week dose adjustment period during which dose titration to 10 mg was allowed.

Study groups in NCT05437224
Study groupRoleWhat they receive
ambrisentanExperimentalOpen Label
Receives: Drug: Ambrisentan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline to 12 weeks and 24weeks in 6-minute Walk Distance

    The 6-minute walk test (6MWT) is a non-encouraged test, performed in a 30 m long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones, with the permission to slow down, rest, or stop if needed. These guidelines were provided to all sites. For patients who had never performed a 6MWT previously, a training test was required before the qualifying tests for inclusion were performed.

    Measured: Baseline, week 12 and week 24

Secondary outcomes (5)

  1. Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH) up to Week 24, Assessed as the First Occurrence of a Clinical Worsening Events

    Clinical Worsening Events included a 15% decrease from baseline on the 6-minute walk test, hospitalization for pulmonary hypertension complications, dosing or escalation of pulmonary hypertension-targeted drugs, atrial septostomy, lung transplantation, or death. Time to clinical worsening of PAH is the time from baseline to the first clinical occurrence of a Clinical Worsening Events.

    Measured: From Baseline to week 24

  2. Change from baseline to week 12 and 24 in Borg Dyspnea Index (BDI) sores

    The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum).

    Measured: Baseline, week 12 and week 24

  3. Number of participants with a change from baseline to week 12 and 24 in WHO functional class

    The WHO FC was determined by the investigator as follows: Class I - Participants with pulmonary hypertension (PH) but without resulting limitation of physical activity; II- Participants with PH resulting in slight limitation of physical activity; III - Participants with PH resulting in marked limitation of physical activity; IV - Participants with PH with inability to carry out any physical activity without symptoms.

    Measured: Baseline, week 12 and week 24

  4. Changes from baseline to week 12 and 24 in BNP plasma levels

    BNP is a surrogate maker of heart failure.

    Measured: Baseline, week 12 and week 24

  5. Number and severity of Participants With Any Adverse Events

    An adverse event is defined as any adverse medical event in a patient that is not necessarily causally related to treatment. An adverse event can thus be any adverse or non-therapeutic sign (including abnormal laboratory results), symptom or disease temporally related to the use of the drug product, whether or not considered drug-related.

    Measured: From Baseline to week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2022
  2. Study start18 Dec 2018
  3. Primary completion9 Jan 2022
  4. Study completion6 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05437224
Sponsor's protocol ID
AMBEL
Acronym
AMBLE
Status last verified
Jun 2022
First submitted
24 Jun 2022
Last updated
29 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wang A, Chen M, Zhuang Q, Guan L, Xie W, Wang L, Huang W, Cheng Z, Yu S, Zhou H, Shen J. Time to clinical improvement: an appropriate surrogate endpoint for pulmonary arterial hypertension medication trials. Front Cardiovasc Med. 2023 Jun 12;10:1142721. doi: 10.3389/fcvm.2023.1142721. eCollection 2023.

    PubMed 37378404

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ambrisentan in people with Pulmonary Arterial Hypertension, run by RenJi Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to 12 weeks and 24weeks in 6-minute Walk Distance (time frame: Baseline, week 12 and week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05437224, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2022.

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