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RNAi Therapeutics
ALN-AGT01 for High Blood Pressure (KARDIA-1 Trial)
Phase 2
Waitlist Available
Research Sponsored by Alnylam Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Daytime mean SBP ≥135 mmHg and ≤160 mmHg by ABPM, without antihypertensive medication
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through month 6
Awards & highlights
KARDIA-1 Trial Summary
This trial is testing a drug to see if it can lower blood pressure. They will also be looking at the drug's safety and how it affects the body.
Who is the study for?
This trial is for adults with mild to moderate high blood pressure, specifically those with a daytime mean systolic blood pressure between 135 and 160 mmHg without medication. It's not for people with high potassium levels, severe kidney issues, uncontrolled or new Type 2 diabetes, recent heart events, Type 1 diabetes, intolerance to injections under the skin (subcutaneous), secondary hypertension, drops in blood pressure upon standing (orthostatic hypotension), or certain liver enzyme elevations.Check my eligibility
What is being tested?
The KARDIA-1 study is testing ALN-AGT01 against a placebo to see its effects on lowering both the top (systolic) and bottom (diastolic) numbers in blood pressure readings. The trial will also look at how the body responds to this drug and its safety profile.See study design
What are the potential side effects?
While specific side effects of ALN-AGT01 are not listed here, common ones may include reactions at the injection site since it's given under the skin. Other potential side effects could be related to changes in kidney function or electrolyte imbalances due to its effect on blood pressure.
KARDIA-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My average daytime blood pressure is between 135 and 160 mmHg without medication.
KARDIA-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through month 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline at Month 3 in 24-hour Mean Systolic Blood Pressure (SBP) Assessed by Ambulatory Blood Pressure Monitoring (ABPM)
Secondary outcome measures
Change from Baseline at Month 3 in Office SBP
Change from Baseline at Month 6 in 24-hour Mean SBP Assessed by ABPM
Change from Baseline at Month 6 in Office SBP
+6 moreKARDIA-1 Trial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: ALN-AGT01 Dose Regimen 4Experimental Treatment1 Intervention
Multiple doses of ALN-AGT01 administered by SC injection during the 12-month DB treatment period.
Group II: ALN-AGT01 Dose Regimen 3Experimental Treatment1 Intervention
Multiple doses of ALN-AGT01 administered by SC injection during the 12-month DB treatment period.
Group III: ALN-AGT01 Dose Regimen 2Experimental Treatment1 Intervention
Multiple doses of ALN-AGT01 administered by SC injection during the 12-month DB treatment period.
Group IV: ALN-AGT01 Dose Regimen 1Experimental Treatment1 Intervention
Multiple doses of ALN-AGT01 administered by subcutaneous (SC) injection during the 12-month DB treatment period.
Group V: Placebo + ALN-AGT01Placebo Group2 Interventions
Multiple doses of placebo administered by SC injection during the first 6 months of 12-month DB treatment period, followed by multiple doses of ALN-AGT01 administered by SC injection during the last 6 months of the 12-month DB treatment period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ALN-AGT01
2019
Completed Phase 1
~130
Find a Location
Who is running the clinical trial?
Alnylam PharmaceuticalsLead Sponsor
72 Previous Clinical Trials
14,424 Total Patients Enrolled
Medical DirectorStudy DirectorAlnylam Pharmaceuticals
2,777 Previous Clinical Trials
8,063,092 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a bad reaction to getting a shot under your skin before.My average daytime blood pressure is between 135 and 160 mmHg without medication.I have recently been diagnosed with Type 2 diabetes.I have not had a heart attack or other heart problems in the last 6 months.I have Type 1 diabetes.Your blood potassium level is higher than 5 mEq/L.My kidney function is low, with an eGFR of 30 or less.My Type 2 diabetes is not well-managed.Your liver enzymes (ALT or AST) are more than double the normal limit.My high blood pressure is caused by another health condition.I experience significant drops in blood pressure when standing up.
Research Study Groups:
This trial has the following groups:- Group 1: ALN-AGT01 Dose Regimen 1
- Group 2: ALN-AGT01 Dose Regimen 2
- Group 3: ALN-AGT01 Dose Regimen 3
- Group 4: ALN-AGT01 Dose Regimen 4
- Group 5: Placebo + ALN-AGT01
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
High Blood Pressure Patient Testimony for trial: Trial Name: NCT04936035 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who would be the ideal candidates to partake in this experiment?
"To meet the eligibility requirements for this medical study, prospective participants must be diagnosed with hypertension and aged between 18-75. A total of 375 individuals are needed to complete this trial's enrollment."
Answered by AI
Are there opportunities for volunteers to participate in this clinical experiment?
"According to clinicaltrials.gov, this research endeavour is currently recruiting participants and was first published on July 7th 2021 with the most recent update occurring in November 15th 2022"
Answered by AI
Is ALN-AGT01 well tolerated by patients?
"Early clinical trials have revealed that ALN-AGT01 is safe, thus it has been assigned a score of 2 on our scale. No efficacy data exists at this point in time."
Answered by AI
Is the trial open to individuals who are less than thirty years old?
"This trial is available to adults between 18 and 75 years old. Those younger than 18 may have the opportunity to enroll in one of 54 clinical trials, while those over 65 can select from 660 studies."
Answered by AI
How many patients is the trial recruiting?
"Affirmative. Clinicaltrials.gov reveals that this medical experiment, which was announced on July 7th 2021 is still recruiting participants. As of now, 375 patients need to be recruited from 85 different clinical sites."
Answered by AI
How many locations in this state are currently conducting research for this undertaking?
"This clinical trial is enlisting individuals at 85 different sites, including Berlin, Red Deer and Holladay. It is recommended that patients choose the nearby clinic to reduce travel-related expenses if they are admitted into the study."
Answered by AI
Who else is applying?
What state do they live in?
Tennessee
Nevada
Other
Texas
How old are they?
65+
18 - 65
What site did they apply to?
Clinical Trial Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0
Why did patients apply to this trial?
To treat hypertension. Trying to find a better solution. I’ve been told so I’m looking into.
PatientReceived no prior treatments
To see if I can my blood pressure in good standing. I've have tried other meds, but non e seems to work.
PatientReceived no prior treatments
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