HypertensionPhase 2NCT05314439
A Study to Assess the Safety, Tolerability, and Efficacy of Monthly Subcutaneous Administration of ION904 in Participants With Uncontrolled Hypertension
A Phase 2 study testing ION904 in people with Hypertension, run by Ionis Pharmaceuticals, Inc. at 8 sites in United States.
Trial summary
The purpose of this study is to evaluate the effect of ION904 on plasma angiotensinogen (AGT) in participants with uncontrolled hypertension. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- ION904
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 8 sitesUnited States
- Study dates
- 29 Apr 2022to 15 Feb 2023
- Phase
- Phase 2
- 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
General Inclusion Criteria:
- Males must be surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential (WOCBP), she uses a highly effective contraceptive method. Aged 18 - 75 inclusive and weighing ≥ 50 kilograms (kg) at the time of informed consent
- Body mass index (BMI) ≤ 45.0 kilograms per square meter (kg/m^2) at screening
- History of uncontrolled hypertension (HTN) on one or more antihypertensive medications without changes in antihypertensive regimen within 4 weeks of screening and will be required to maintain this regimen throughout the Treatment Period
General Exclusion Criteria:
- History of secondary HTN including, but not limited to any of the following: renovascular HTN (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug induced HTN
- Unstable/underlying known cardiovascular disease defined as:
- Any history of congestive heart failure (New York Heart Association [NYHA] Class III-IV)
- Any history of previous myocardial infarction, coronary revascularization, unstable or stable angina pectoris ˂ 6 months prior to screening
- Any hemodynamically unstable atrial or ventricular arrhythmias
- Significant uncorrected valvular heart disease
- Any history of stroke or transient ischemic attack < 6 months prior to screening
- A cardiac valve repair, cardiac device implantation, and/or a hospitalization for heart failure within 3 months of screening
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
NY Scientific
Brooklyn, New York, 11235
ALL Medical Research, LLC
Cooper City, Florida, 33024
Altasciences - Los Angeles
Cypress, California, 90630
Juno Research, LLC
Houston, Texas, 77040
National Research Institute
Los Angeles, California, 90057
Altasciences
Overland Park, Kansas, 66212
Progressive Medical Research
Port Orange, Florida, 32127
Clinical Trials Research
Sacramento, California, 95821
About this study
Official title: A Double-Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of Monthly Subcutaneous Administration of ION904 in Patients With Uncontrolled Hypertension
The purpose of this study is to evaluate the effect of ION904 on plasma angiotensinogen (AGT) in participants with uncontrolled hypertension.
Read the detailed description
This is a Phase 2, multicenter, double-blind, randomized, placebo-controlled study. It will include up to approximately 48 participants with mild to moderate hypertension who have uncontrolled blood pressure (˃ 130 - ≤ 170 millimeters of mercury [mmHg] systolic) and have been on one or more anti-hypertensive medications for at least one month. Following an up to 4-week screening period, eligible participants will receive multiple doses of ION904 during a 13-week treatment period, followed by a 13-week post-treatment follow-up period.
- Conditions
- Hypertension
- Being tested
- ION904, Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ION904Drug
ION904 will be administered by SC injection.
PlaceboDrug
Placebo will be administered by SC injection.
| Study group | Role | What they receive |
|---|---|---|
| ION904 | Experimental | Up to 4 monthly doses of ION904 will be administered by subcutaneous (SC) injection. Receives: Drug: ION904 |
| Placebo | Placebo comparator | Up to 4 monthly doses of placebo will be administered by SC injection. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change from Baseline in Plasma Angiotensinogen (AGT)
Measured: Baseline up to approximately 15 weeks
Secondary outcomes (2)
Change from Baseline in Seated Automated Office Systolic Blood Pressure (SBP)
Measured: Baseline up to approximately 15 weeks
Change from Baseline in Seated Automated Office Diastolic Blood Pressure (DBP)
Measured: Baseline up to approximately 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start29 Apr 2022
- Primary completion31 Jan 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Ionis Pharmaceuticals, Inc.The sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ionis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314439
- Sponsor's protocol ID
- ION904-CS2
- Other IDs
- 2022-000140-30
- Status last verified
- Dec 2023
- First submitted
- 29 Mar 2022
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of Monthly Subcutaneous Administration of ION904 in Patients With Uncontrolled Hypertension
- ClinicalTrials.gov ID
- NCT05314439
- Acronym / sponsor ID
- ION904-CS2
- Conditions
- Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ionis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 6 Apr 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.
The purpose of this study is to evaluate the effect of ION904 on plasma angiotensinogen (AGT) in participants with uncontrolled hypertension.
Detailed description
This is a Phase 2, multicenter, double-blind, randomized, placebo-controlled study. It will include up to approximately 48 participants with mild to moderate hypertension who have uncontrolled blood pressure (˃ 130 - ≤ 170 millimeters of mercury [mmHg] systolic) and have been on one or more anti-hypertensive medications for at least one month. Following an up to 4-week screening period, eligible participants will receive multiple doses of ION904 during a 13-week treatment period, followed by a 13-week post-treatment follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ION904 | Experimental | Drug: ION904Up to 4 monthly doses of ION904 will be administered by subcutaneous (SC) injection. |
| Placebo | Placebo comparator | Drug: PlaceboUp to 4 monthly doses of placebo will be administered by SC injection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| ION904ION904 will be administered by SC injection. | Drug | ION904 |
| PlaceboPlacebo will be administered by SC injection. | Drug | Placebo |
Primary outcome
Percent Change from Baseline in Plasma Angiotensinogen (AGT)
Time frame: Baseline up to approximately 15 weeks
2 secondary outcomes
Change from Baseline in Seated Automated Office Systolic Blood Pressure (SBP)
Time frame: Baseline up to approximately 15 weeks
Change from Baseline in Seated Automated Office Diastolic Blood Pressure (DBP)
Time frame: Baseline up to approximately 15 weeks
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 22 Dec 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ION904 in people with Hypertension, run by Ionis Pharmaceuticals, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percent Change from Baseline in Plasma Angiotensinogen (AGT) (time frame: Baseline up to approximately 15 weeks). 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 22 Dec 2023.