Clinical trial NCT05314439: A Study to Assess the Safety, Tolerability, and Efficacy of Monthly Subcutaneous Administration of ION904 in Participants With Uncontrolled Hypertension
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Lead sponsor: Ionis Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-06
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: General Inclusion Criteria:

1. 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
2. Body mass index (BMI) ≤ 45.0 kilograms per square meter (kg/m\^2) at screening
3. 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:

1. 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
2. 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
3. A cardiac valve repair, cardiac device implantation, and/or a hospitalization for heart failure within 3 months of screening

Primary outcomes:
measure: Percent Change from Baseline in Plasma Angiotensinogen (AGT)
timeFrame: Baseline up to approximately 15 weeks
Secondary outcomes:
measure: Change from Baseline in Seated Automated Office Systolic Blood Pressure (SBP)
timeFrame: Baseline up to approximately 15 weeks
measure: Change from Baseline in Seated Automated Office Diastolic Blood Pressure (DBP)
timeFrame: Baseline up to approximately 15 weeks
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Altasciences - Los Angeles
state: California
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: Sacramento
country: United States
facility: Clinical Trials Research
state: California
city: Cooper City
country: United States
facility: ALL Medical Research, LLC
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Overland Park
country: United States
facility: Altasciences
state: Kansas
city: Brooklyn
country: United States
facility: NY Scientific
state: New York
city: Houston
country: United States
facility: Juno Research, LLC
state: Texas
Study officials:
References: