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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03714776
Other study ID # ISIS 757456-CS2
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 3, 2019
Est. completion date November 13, 2019

Study information

Verified date December 2022
Source Ionis Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This was a Phase 2, double-blind, randomized, placebo-controlled study of IONIS-AGT-LRx conducted in mild hypertensive participants.


Description:

Participants were randomized in a 2:1 ratio to receive a once-weekly subcutaneous treatment and an additional loading dose on Study Day 3 with either IONIS-AGT-LRx or placebo for 6 weeks. All participants completed a 13-week Post-Treatment Period.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date November 13, 2019
Est. primary completion date November 13, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 72 Years
Eligibility Inclusion Criteria 1. Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal. 2. Males must be surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential, the participant or the participant's non-pregnant female partner must be using a highly effective contraceptive method 3. Body Mass Index (BMI) = 35.0 kg/m2 4. Participant must have been diagnosed with essential hypertension for a minimum of 3 months prior to screening 5. At Screening, on a stable regimen of antihypertensive medications for at least 1 month prior to screening 6. Agree to conduct at home Blood Pressure (BP) and Heart Rate (HR) monitoring three times weekly and document the average of the triplicate measurements assessed on a day in the patient diary Exclusion Criteria 1. Clinically-significant (CS) abnormalities in medical history, screening laboratory results, physical or physical examination that would render a participant unsuitable for inclusion 2. The use of the following at time of screening and during the course of the study: 1. Other medications for the treatment of hypertension (e.g., clonidine, guanfacine, guanabenz, alpha-methyldopa, hydralazine, minoxidil, diazoxide, renin inhibitors) 2. Medications that also may cause hyperkalemia (e.g., cyclosporine or tacrolimus, pentamidine, trimethoprim-sulfamethoxazole, all heparins) 3. Oral or subcutaneous anticoagulants (e.g., warfarin, rivaroxaban, apixaban, heparin, lovenox) 4. Organic nitrate preparations (e.g., nitroglycerin, isosorbide mononitrate, isosorbide dinitrate, or pentaerythritol) 5. Sildenafil, tadalafil, vardenafil 3. Unwilling to discontinue antihypertensive mediations during Wash Out (WO) and Treatment Period of study 4. Participant has a history of secondary hypertension 5. Unstable/underlying cardiovascular disease defined as: 1. Any history of congestive heart failure (NYHA class II-IV) 2. Any history of previous stroke, transient ischemic attack, unstable or stable angina pectoris, or myocardial infarction prior to screening 3. a history or evidence of long QT syndrome 4. Any CS active atrial or ventricular arrhythmias 5. Any history of coronary bypass or percutaneous coronary intervention

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Placebo
Placebo matching solution administered as SC injection.
ISIS 757456
Administered as SC injection.

Locations

Country Name City State
United States Juno Research, LLC - Northwest Site Houston Texas
United States Midwest Institute for Clinical Research Indianapolis Indiana
United States Ohio Clinical Research - Lyndhurst Lyndhurst Ohio
United States York Clinical Research LLC Norfolk Virginia
United States Progressive Medical Research Port Orange Florida
United States Orange County Research Center Tustin California

Sponsors (1)

Lead Sponsor Collaborator
Ionis Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent Change From Baseline in Plasma Angiotensinogen (AGT) at Day 43 (Week 7) Compared to Placebo Baseline, Week 7
Secondary Change From Baseline in the In-clinic Systolic Blood Pressure (SBP) at Days 3, 8, 15, 22, 29, and 36 Baseline, Days 3, 8, 15, 22, 29, and 36
Secondary Percent Change From Baseline in Plasma AGT at Days 3, 8, 15, 22, 29 and 36 Baseline, Days 3, 8, 15, 22, 29, and 36
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