Tachycardia, SupraventricularPhase 3NCT05410860
Efficacy and Safety Study of Etripamil Nasal Spray Self-Administration for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia
A Phase 3 study testing Etripamil NS 70 mg in people with Tachycardia, Supraventricular and Paroxysmal Supraventricular Tachycardia, run by Corxel Pharmaceuticals at 53 sites in China.
Trial summary
To determine whether etripamil nasal spray (NS) self-administered by Chinese patients is superior to placebo at terminating episodes of PSVT in an at-home setting； To evaluate the efficacy of etripamil NS self-administered by Chinese patients compared with placebo on a range of clinical markers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachycardia, Supraventricular, Paroxysmal Supraventricular Tachycardia
- What is being tested?
- Etripamil NS 70 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 53 sitesChina
- Study dates
- 30 Jun 2022to 10 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet all of the following criteria will be eligible to participate in the study:
- Male or female patients at least 18 years of age;
- Electrographically documented history of PSVT (e.g., diagnosis based on ECG , Holter monitoring, etc.). If patient had a prior ablation for PSVT, patient must have documented ECG evidence of PSVT post-ablation;
- History of sustained episodes of PSVT (i.e., typically lasting 20 minutes or longer);
- Females of childbearing potential who are sexually active with a male partner who is not surgically sterile (i.e., vasectomy) must agree to use an approved highly effective form of contraception from the time of signed informed consent until 30 days after the last administration of study drug.;
- The following categories define females who are NOT considered to be of childbearing potential:
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- Premenopausal females with 1 of the following:
- Documented hysterectomy;
- Documented bilateral salpingectomy or tubal ligation; or
- Documented bilateral oophorectomy; or
- Postmenopausal females, defined as having amenorrhea for at least 12 months without an alternative medical cause; and
- Signed written informed consent.
Who cannot join
- Patients who meet any of the following criteria will be excluded from participation in the study:
- Systolic blood pressure (SBP) <90 mmHg after a 5-minute rest in sitting position at the Screening Visit or before the test dose. In patients treated with a chronic prophylactic drug for PSVT (e.g., beta blockers, verapamil, and diltiazem), the drug may be stopped for at least the equivalent of 5 half-lives, patients may be rescreened once, and chronic use of the drug cannot be restarted after randomization;
- History of severe symptoms of hypotension, especially syncope, during episodes of PSVT;
- History of atrial arrhythmia that does not involve the atrioventricular (AV) node as part of the tachycardia circuit (e.g., atrial fibrillation, atrial flutter, intra-atrial tachycardia);
- History of allergic reaction to verapamil;
- Current therapy with digoxin or any Class I or III antiarrhythmic drug, except if these drugs are stopped at least the equivalent of 5 half-lives before the Test Dose Randomization Visit;
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- Current chronic therapy with oral amiodarone, or have taken oral amiodarone within 30 days prior to the Test Dose Randomization Visit;
- Evidence of ventricular pre-excitation (e.g., delta waves, short PR interval <100 msec, Wolff Parkinson White syndrome) on the ECG performed at the Screening Visit or before the test dose administration;
- Evidence of a second- or third-degree AV block on the ECG performed at the Screening Visit or before the test dose administration;
- History or evidence of severe ventricular arrhythmia (e.g., torsades de pointes, ventricular fibrillation, or ventricular tachycardia);
- Current congestive heart failure defined by the New York Heart Association Class II to IV;
- History of Acute Coronary Syndrome or stroke within 6 months of screening;
- Evidence of hepatic dysfunction ;
- Evidence of End-Stage Renal Disease;
- Females who are pregnant or lactating;
- Evidence or history of any significant physical or psychiatric condition including drug abuse, which, in the opinion of the Investigator, could jeopardize the safety of patients or affect their participation in the study. Additionally, the Investigator has the ability to exclude a patient if for any reason the Investigator judges the patient is not a good candidate for the study (e.g., illiteracy or poor understanding) or will not be able to follow study procedures;
- Participation in any investigational drug or device study or the use of any investigational drug or device within 30 days or five terminal phase half-lives of the drug whichever is longer, prior to the Screening Visit; or
- Previously enrolled in a clinical trial for Etripamil and received study drug during a perceived episode of PSVT;
- An immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.
- Before randomization in this study, all patients will receive a test dose of an etripamil NS dosing regimen.
Trial locations and contacts
53 sites in 1 country.
53 sites in 1 country
China53 sites
Baotou Central Hospital
Baotou
The First Affiliated Hospital of Baotou Medical College
Baotou
Beijing Anzhen Hospital; Capital Medical University
Beijing, 100032
Beijing Hospital
Beijing
Beijing Tongren Hospital, Capital Medical University
Beijing
Chui Yang Liu Hospital Affiliated to Tsinghua University
Beijing
Peking Union Medical College Hospital
Beijing
The Central Hospital of China Aerospace Corporation
Beijing
The First Affiliated Hospital of Bengbu Medical College
Bengbu
The First Hospital of Jilin University
Ch’ang-ch’un
The Third Xiangya Hospital of Central South University
Changsha
Xiangya Hospital, Central South University
Changsha
Changzhou No.2 People's Hospital
Changzhou
The First Affiliated Hospital of Chengdu Medical College
Chengdu
Affiliated Zhongshan Hospital of Dalian University
Dalian
People's Hospital of Deyang City
Deyang
The First Affiliated Hospital of Fujian Medical University
Fuzhou
Nanfang Hospital of Southern Medical University
Guangzhou
Guizhou Provincial People's Hospital
Guiyang
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou
The First People's Hospital of Hangzhou Linping District
Hangzhou
Zhejiang Provincial People's Hospital
Hangzhou
Huai'an First People's Hospital
Huai'an
Huainan First People's Hospital
Huainan
Huizhou Municipal Central Hospital
Huizhou
Jinan Central Hospital
Jinan
Shandong Province Qianfoshan Hospital
Jinan
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou
Lanzhou University Second Hospital
Lanzhou
Lishui Municipal Central Hospital
Lishui
The First Affiliated Hospital of Henan Science and Technology University
Luoyang
Mianyang Central Hospital
Mianyang
The Nanchang Third Hospital
Nanchang
The Second Affiliated Hospital of Nanchang University
Nanchang
Jiangsu Province Hospital
Nanjing
Nanjing Drum Tower Hospital
Nanjing
Guangxi Zhuang Autonomous Region People's Hospital
Nanning
The second affiliated Hospital of Guangxi Medical University
Nanning
Nanyang Second General Hospital
Nanyang
Ningbo First Hospital
Ningbo
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
Shanghai
Shanghai Pudong New Area People's Hospital
Shanghai
Shanghai Tongren Hospital
Shanghai
Shangrao People's Hospital
Shangrao
Shanxi Cardiovascular Hospital
Taiyuan
Jiangsu Taizhou People's Hospital
Taizhou
Binhai Hospital (Tianjin Fifth Central Hospital)
Tianjin
Tianjin Medical University General Hospital
Tianjin
CR and WISCO General Hospital
Wuhan
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan
Xingtai Third Hospital
Xingtai
The Fourth Affiliated Hospital Zhejiang University School of Medicine
Yiwu
ZiBo Central Hospital
Zibo
About this study
Official title: Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Etripamil Nasal Spray Self-Administration for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia in Chinese Patients
To determine whether etripamil nasal spray (NS) self-administered by Chinese patients is superior to placebo at terminating episodes of PSVT in an at-home setting； To evaluate the efficacy of etripamil NS self-administered by Chinese patients compared with placebo on a range of clinical markers.
To evaluate the safety of etripamil NS self-administered by Chinese patients compared with placebo
Read the detailed description
The study is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etripamil NS self-administered by patients who experience an episode of PSVT in an at-home setting.
This is an event-driven study. Enrollment into the study will continue until the adjudication of the 180th positively adjudicated PSVT episode in patients treated with double-blind study drug during the Randomized Treatment Period required for the study's pivotal analysis. After the date of the adjudication of the 180th positively adjudicated PSVT episode, all randomized patients will be unblinded at this timepoint and enter into an approximately 6 months open-label period of the study.
- Being tested
- Etripamil NS 70 mg, Placebo
- Keywords
- Etripamil, Paroxysmal supraventricular tachycardia, Cardiac monitoring, Calcium channel blocker, Conversion rate, Chinese patient
- Medical subject headings
- Tachycardia, Supraventricular, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etripamil NS 70 mgDrug
Etripamil NS 70 mg will be administered via the Aptar Pharma Nasal Spray Bidose System, supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box.
PlaceboDrug
Placebo will be administered via the Aptar Pharma Nasal Spray Bidose System, supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box.
| Study group | Role | What they receive |
|---|---|---|
| Etripamil NS 70 mg with Optional Second Dose | Experimental | Dosing regimen that permits a second dose of Etripamil NS 70 mg Receives: Drug: Etripamil NS 70 mg |
| Placebo with Optional Second Dose | Experimental | Dosing regimen that permits a second dose of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to an adjudicated termination of a positively adjudicated episode of PSVT and conversion to sinus rhythm (SR) for at least 30 seconds within 30 minutes of start of study drug dosing
The primary efficacy endpoint is defined as an adjudicated termination of a positively adjudicated episode of PSVT (AV nodal reentrant tachycardia or AV reentrant tachycardia determination if possible) and conversion to sinus rhythm (SR) for at least 30 seconds within 30 minutes of start of study drug dosing.
Measured: Within 30 minutes of start of study drug dosing.
Secondary outcomes (7)
Time to conversion at time points of 5, 10, 15, 45, and 60 minutes
Measured: 1 hour after administration of study drug
Time to conversion in patients with the option of repeat administration
Measured: 1 hour after administration of study drug
The percentage of patients requiring additional medical intervention in emergency department to terminate an episode of PSVT
Measured: Up to 2 years
Number of participants with relief of specific symptoms (i.e., heart palpitations, rapid pulse feeling, chest pain, anxiety, shortness of breath, dizziness, and fainting)
Measured: 1 hour after administration of study drug
Rating of Treatment Satisfaction Questionnaire for Medication (TSQM).
Treatment satisfaction will be analyzed by comparing the Treatment Satisfaction Questionnaire for Medication 9(TSQM-9) score for satisfaction in the 2 treatment groups. The TSQM-9 is composed of 9 questions with responses on a scale of 1 (extremely dissatisfied) to 7 (extremely satisfied). A higher score indicated greater satisfaction with medication.
Measured: 1 hour after administration of study drug
The percentage of adverse event
Measured: Up to 2 years
Number of participants with arrhythmias and conduction disorders detected on surface electrocardiogram（ECG） or cardiac monitoring system (CMS) recordings.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start30 Jun 2022
- Primary completion2 Aug 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tachycardia, SupraventricularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients who pass the test dose of the Etripamil NS dosing regimen will be randomized in a 1:1 ratio to Etripamil NS 70mg or placebo using an Interactive Response Technology (IRT) system.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corxel Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Milestone Pharmaceuticals Inc.
- Responsible party
- Sponsor
- Investigators
- Xiaowen Chen, Study director, Corxel PharmaceuticalsChangsheng Ma, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410860
- Sponsor's protocol ID
- JX02002
- Other IDs
- CTR20221163
- Status last verified
- Sep 2024
- First submitted
- 5 Jun 2022
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Etripamil Nasal Spray Self-Administration for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia in Chinese Patients
- ClinicalTrials.gov ID
- NCT05410860
- Acronym / sponsor ID
- JX02002
- Keywords
- Etripamil, Paroxysmal supraventricular tachycardia, Cardiac monitoring, Calcium channel blocker, Conversion rate, Chinese patient
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Corxel PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Milestone Pharmaceuticals Inc.
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 2 Aug 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether etripamil nasal spray (NS) self-administered by Chinese patients is superior to placebo at terminating episodes of PSVT in an at-home setting； To evaluate the efficacy of etripamil NS self-administered by Chinese patients compared with placebo on a range of clinical markers.
To evaluate the safety of etripamil NS self-administered by Chinese patients compared with placebo
Detailed description
The study is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etripamil NS self-administered by patients who experience an episode of PSVT in an at-home setting.
This is an event-driven study. Enrollment into the study will continue until the adjudication of the 180th positively adjudicated PSVT episode in patients treated with double-blind study drug during the Randomized Treatment Period required for the study's pivotal analysis. After the date of the adjudication of the 180th positively adjudicated PSVT episode, all randomized patients will be unblinded at this timepoint and enter into an approximately 6 months open-label period of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Patients who pass the test dose of the Etripamil NS dosing regimen will be randomized in a 1:1 ratio to Etripamil NS 70mg or placebo using an Interactive Response Technology (IRT) system.
| Arm | Type | Receives |
|---|---|---|
| Etripamil NS 70 mg with Optional Second Dose | Experimental | Drug: Etripamil NS 70 mgDosing regimen that permits a second dose of Etripamil NS 70 mg |
| Placebo with Optional Second Dose | Experimental | Drug: PlaceboDosing regimen that permits a second dose of placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients who meet all of the following criteria will be eligible to participate in the study:
- Male or female patients at least 18 years of age;
- Electrographically documented history of PSVT (e.g., diagnosis based on ECG , Holter monitoring, etc.). If patient had a prior ablation for PSVT, patient must have documented ECG evidence of PSVT post-ablation;
- History of sustained episodes of PSVT (i.e., typically lasting 20 minutes or longer);
- Females of childbearing potential who are sexually active with a male partner who is not surgically sterile (i.e., vasectomy) must agree to use an approved highly effective form of contraception from the time of signed informed consent until 30 days after the last administration of study drug.;
Key exclusion criteria (20 listed)
- Patients who meet any of the following criteria will be excluded from participation in the study:
- Systolic blood pressure (SBP) <90 mmHg after a 5-minute rest in sitting position at the Screening Visit or before the test dose. In patients treated with a chronic prophylactic drug for PSVT (e.g., beta blockers, verapamil, and diltiazem), the drug may be stopped for at least the equivalent of 5 half-lives, patients may be rescreened once, and chronic use of the drug cannot be restarted after randomization;
- History of severe symptoms of hypotension, especially syncope, during episodes of PSVT;
- History of atrial arrhythmia that does not involve the atrioventricular (AV) node as part of the tachycardia circuit (e.g., atrial fibrillation, atrial flutter, intra-atrial tachycardia);
- History of allergic reaction to verapamil;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etripamil NS 70 mgEtripamil NS 70 mg will be administered via the Aptar Pharma Nasal Spray Bidose System, supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box. | Drug | Etripamil NS 70 mg with Optional Second Dose |
| PlaceboPlacebo will be administered via the Aptar Pharma Nasal Spray Bidose System, supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box. | Drug | Placebo with Optional Second Dose |
Primary outcome
Time to an adjudicated termination of a positively adjudicated episode of PSVT and conversion to sinus rhythm (SR) for at least 30 seconds within 30 minutes of start of study drug dosing
Time frame: Within 30 minutes of start of study drug dosing.
The primary efficacy endpoint is defined as an adjudicated termination of a positively adjudicated episode of PSVT (AV nodal reentrant tachycardia or AV reentrant tachycardia determination if possible) and conversion to sinus rhythm (SR) for at least 30 seconds within 30 minutes of start of study drug dosing.
7 secondary outcomes
Time to conversion at time points of 5, 10, 15, 45, and 60 minutes
Time frame: 1 hour after administration of study drug
Time to conversion in patients with the option of repeat administration
Time frame: 1 hour after administration of study drug
The percentage of patients requiring additional medical intervention in emergency department to terminate an episode of PSVT
Time frame: Up to 2 years
Number of participants with relief of specific symptoms (i.e., heart palpitations, rapid pulse feeling, chest pain, anxiety, shortness of breath, dizziness, and fainting)
Time frame: 1 hour after administration of study drug
Rating of Treatment Satisfaction Questionnaire for Medication (TSQM).
Time frame: 1 hour after administration of study drug
The percentage of adverse event
Time frame: Up to 2 years
Number of participants with arrhythmias and conduction disorders detected on surface electrocardiogram（ECG） or cardiac monitoring system (CMS) recordings.
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaowen Chen study director
Corxel Pharmaceuticals
Changsheng Ma principal investigator
Beijing Anzhen Hospital
53 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Etripamil NS 70 mg in people with Tachycardia, Supraventricular and Paroxysmal Supraventricular Tachycardia, run by Corxel Pharmaceuticals at 53 sites 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 12 inclusion and 20 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 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites 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?
Time to an adjudicated termination of a positively adjudicated episode of PSVT and conversion to sinus rhythm (SR) for at least 30 seconds within 30 minutes of start of study drug dosing (time frame: Within 30 minutes of start of study drug dosing.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.