Zilebesiran as Add-on Therapy in Patients With High Cardiovascular Risk and Hypertension Not Adequately Controlled by Standard of Care Antihypertensive Medications (KARDIA-3) (KARDIA-3)

February 27, 2026 updated by: Alnylam Pharmaceuticals

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Zilebesiran Used as Add-on Therapy in Adult Patients With High Cardiovascular Risk and Hypertension Not Adequately Controlled by Standard of Care Antihypertensive Medications

The purpose of this study is to evaluate the effect of zilebesiran as add-on therapy in patients with high cardiovascular risk and hypertension not adequately controlled by standard of care antihypertensive medications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

375

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- - Blacktown, Australia, 2148
    - Clinical Trial Site
  - Brookvale, Australia, 2100
    - Clinical Trial Site
  - Bruce, Australia, 2617
    - Clinical Trial Site
  - Concord, Australia, 2139
    - Clinical Trial Site
  - Garran, Australia, 2605
    - Clinical Trial Site
  - Kanwal, Australia, 2259
    - Clinical Trial Site
  - Kogarah, Australia, 2217
    - Clinical Trial Site
  - Perth, Australia, 6000
    - Clinical Trial Site
  - Sippy Downs, Australia, 4556
    - Clinical Trial Site
  - St Leonards, Australia, 2065
    - Clinical Trial Site
  - Tarragindi, Australia, 4121
    - Clinical Trial Site
Canada
- - Brampton, Canada, L6T 0G1
    - Clinical Trial Site
  - Chicoutimi, Canada, G7H 7K9
    - Clinical Trial Site
  - Greenfield Park, Canada, J4V 2G8
    - Clinical Trial Site
  - Montreal, Canada, H4J 1C5
    - Clinical Trial Site
  - Montreal, Canada, H4N 2W2
    - Clinical Trial Site
  - QuÃ©bec, Canada, G1W 4R4
    - Clinical Trial Site
  - Québec, Canada, G1V 4T3
    - Clinical Trial Site
  - Sainte-Foy, Canada, G1V 4G5
    - Clinical Trial Site
  - Sarnia, Canada, N7T 4X3
    - Clinical Trial Site
  - Toronto, Canada, M3J 0K2
    - Clinical Trial Site
  - Toronto, Canada, M4P 1E4
    - Clinical Trial Site
  - Toronto, Canada, M5B 1W8
    - Clinical Trial Site
  - Trois-Rivières, Canada, G9A 4P3
    - Clinical Trial Site
  - Waterloo, Canada, N2T 0C1
    - Clinical Trial Site
  - Winnipeg, Canada, R2V 3M3
    - Clinical Trial Site
Puerto Rico
- - Ponce, Puerto Rico, 00716
    - Clinical Trial Site
  - Toa Baja, Puerto Rico, 00949
    - Clinical Trial Site
Switzerland
- - Basel, Switzerland, 4031
    - Clinical Trial Site
  - Geneva, Switzerland, 1205
    - Clinical Trial Site
  - Lausanne, Switzerland, 1005
    - Clinical Trial Site
  - Lucerne, Switzerland, 6000
    - Clinical Trial Site
United Kingdom
- - Bellshill, United Kingdom, ML4 3NJ
    - Clinical Trial Site
  - Birmingham, United Kingdom, B15 2SQ
    - Clinical Trial Site
  - Bristol, United Kingdom, BS2 8HW
    - Clinical Trial Site
  - Canterbury, United Kingdom, CT1 3NG
    - Clinical Trial Site
  - Cardiff, United Kingdom, CF15 9SS
    - Clinical Trial Site
  - Carshalton, United Kingdom, SM5 1AA
    - Clinical Trial Site
  - Chesterfield, United Kingdom, S40 4AA
    - Clinical Trial Site
  - Chorley, United Kingdom, PR7 7NA
    - Clinical Trial Site
  - Fowey, United Kingdom, PL23 1DT
    - Clinical Trial Site
  - Glasgow, United Kingdom, G51 4TF
    - Clinical Trial Site
  - Glasgow, United Kingdom, G20 7BE
    - Clinical Trial Site
  - Hexham, United Kingdom, NE46 1QJ
    - Clinical Trial Site
  - Leicester, United Kingdom, LE5 4PW
    - Clinical Trial Site
  - Liskeard, United Kingdom, PL14 3XA
    - Clinical Trial Site
  - Liverpool, United Kingdom, L22 0LG
    - Clinical Trial Site
  - London, United Kingdom, SE1 1YR
    - Clinical Trial Site
  - London, United Kingdom, SW17 0QT
    - Clinical Trial Site
  - London, United Kingdom, EC1A 7BE
    - Clinical Trial Site
  - Luton, United Kingdom, LU4 0DZ
    - Clinical Trial Site
  - Manchester, United Kingdom, M15 6SE
    - Clinical Trial Site
  - Newquay, United Kingdom, TR7 1RU
    - Clinical Trial Site
  - Pickering, United Kingdom, YO18 8BL
    - Clinical Trial Site
  - Plymouth, United Kingdom, PL5 3JB
    - Clinical Trial Site
  - Torpoint, United Kingdom, PL11 2TB
    - Clinical Trial Site
United States
- Alabama
  - Alexander City, Alabama, United States, 35010
    - Clinical Trial Site
  - Daphne, Alabama, United States, 36526
    - Clinical Trial Site
  - Foley, Alabama, United States, 36535
    - Clinical Trial Site
  - Huntsville, Alabama, United States, 35801
    - Clinical Trial Site
  - Huntsville, Alabama, United States, 35805
    - Clinical Trial Site
  - Montgomery, Alabama, United States, 36117
    - Clinical Trial Site
- Arizona
  - Gilbert, Arizona, United States, 85297
    - Clinical Trial Site
  - Phoenix, Arizona, United States, 85028
    - Clinical Trial Site
  - Sun City, Arizona, United States, 85351
    - Clinical Trial Site
  - Tempe, Arizona, United States, 85281
    - Clinical Trial Site
  - Tucson, Arizona, United States, 85741
    - Clinical Trial Site
- California
  - Beverly Hills, California, United States, 90211
    - Clinical Trial Site
  - Covina, California, United States, 91723
    - Clinical Trial Site
  - Encinitas, California, United States, 92024
    - Clinical Trial Site
  - Garden Grove, California, United States, 92844
    - Clinical Trial Site
  - Huntington Beach, California, United States, 92647
    - Clinical Trial Site
  - Los Angeles, California, United States, 90057
    - Clinical Trial Site
  - Los Angeles, California, United States, 90022
    - Clinical Trial Site
  - Northridge, California, United States, 91324
    - Clinical Trial Site
  - Northridge, California, United States, 91325
    - Clinical Trial Site
  - Pasadena, California, United States, 91105
    - Clinical Trial Site
  - San Diego, California, United States, 92108
    - Clinical Trial Site
  - San Diego, California, United States, 92111
    - Clinical Trial Site
  - San Dimas, California, United States, 91773
    - Clinical Trial Site
  - Simi Valley, California, United States, 93065
    - Clinical Trial Site
  - Vacaville, California, United States, 95687
    - Clinical Trial Site
  - Van Nuys, California, United States, 91405
    - Clinical Trial Site
  - West Hills, California, United States, 91307
    - Clinical Trial Site
- Colorado
  - Colorado Springs, Colorado, United States, 80918
    - Clinical Trial Site
  - Denver, Colorado, United States, 80210
    - Clinical Trial Site
  - Denver, Colorado, United States, 80230
    - Clinical Trial Site
- Connecticut
  - Hartford, Connecticut, United States, 06112
    - Clinical Trial Site
  - Middlebury, Connecticut, United States, 06762
    - Clinical Trial Site
  - Waterbury, Connecticut, United States, 06708
    - Clinical Trial Site
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20009
    - Clinical Trial Site
- Florida
  - Clearwater, Florida, United States, 33756
    - Clinical Trial Site
  - Coral Gables, Florida, United States, 33134
    - Clinical Trial Site
  - Daytona Beach, Florida, United States, 32117
    - Clinical Trial Site
  - Fort Myers, Florida, United States, 33912
    - Clinical Trial Site
  - Hollywood, Florida, United States, 33021
    - Clinical Trial Site
  - Jacksonville, Florida, United States, 32209
    - Clinical Trial Site
  - Jacksonville, Florida, United States, 32256
    - Clinical Trial Site
  - Jacksonville, Florida, United States, 32204
    - Clinical Trial Site
  - Jensen Beach, Florida, United States, 34957
    - Clinical Trial Site
  - Lake City, Florida, United States, 32055
    - Clinical Trial Site
  - Miami, Florida, United States, 33126
    - Clinical Trial Site
  - Miami, Florida, United States, 33144
    - Clinical Trial Site
  - Miami, Florida, United States, 33135
    - Clinical Trial Site
  - Miami, Florida, United States, 33137
    - Clinical Trial Site
  - Miami, Florida, United States, 33176
    - Clinical Trial Site
  - Miami, Florida, United States, 33155
    - Clinical Trial Site
  - Miramar, Florida, United States, 33027
    - Clinical Trial Site
  - Orlando, Florida, United States, 32801
    - Clinical Trial Site
  - The Villages, Florida, United States, 32162
    - Clinical Trial Site
  - Winter Haven, Florida, United States, 33880
    - Clinical Trial Site
- Georgia
  - Acworth, Georgia, United States, 30101
    - Clinical Trial Site
  - Atlanta, Georgia, United States, 30322
    - Clinical Trial Site
  - Columbus, Georgia, United States, 31904
    - Clinical Trial Site
  - Douglasville, Georgia, United States, 30134
    - Clinical Trial Site
  - Gainesville, Georgia, United States, 30501
    - Clinical Trial Site
  - Savannah, Georgia, United States, 31406
    - Clinical Trial Site
  - Thomasville, Georgia, United States, 31792
    - Clinical Trial Site
- Idaho
  - Boise, Idaho, United States, 83706
    - Clinical Trial Site
- Illinois
  - Chicago, Illinois, United States, 60602
    - Clinical Trial Site
- Indiana
  - Elkhart, Indiana, United States, 46514
    - Clinical Trial Site
  - Evansville, Indiana, United States, 47714
    - Clinical Trial Site
  - Richmond, Indiana, United States, 47374
    - Clinical Trial Site
- Kansas
  - El Dorado, Kansas, United States, 67042
    - Clinical Trial Site
  - Newton, Kansas, United States, 67114
    - Clinical Trial Site
  - Wichita, Kansas, United States, 67207
    - Clinical Trial Site
- Kentucky
  - Owensboro, Kentucky, United States, 42303
    - Clinical Trial Site
- Louisiana
  - Monroe, Louisiana, United States, 71201
    - Clinical Trial Site
  - New Orleans, Louisiana, United States, 70119
    - Clinical Trial Site
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Clinical Trial Site
  - West Springfield, Massachusetts, United States, 01089
    - Clinical Trial Site
- Michigan
  - Flint, Michigan, United States, 48504
    - Clinical Trial Site
  - Shelby, Michigan, United States, 48315
    - Clinical Trial Site
  - Ypsilanti, Michigan, United States, 48197
    - Clinical Trial Site
- Minnesota
  - Minneapolis, Minnesota, United States, 55404
    - Clinical Trial Site
  - Richfield, Minnesota, United States, 55423
    - Clinical Trial Site
- Mississippi
  - Columbus, Mississippi, United States, 39705
    - Clinical Trial Site
  - Tupelo, Mississippi, United States, 38801
    - Clinical Trial Site
- Missouri
  - Creve Coeur, Missouri, United States, 63141
    - Clinical Trial Site
- Montana
  - Kalispell, Montana, United States, 59901
    - Clinical Trial Site
- Nebraska
  - Lincoln, Nebraska, United States, 68510
    - Clinical Trial Site
  - Omaha, Nebraska, United States, 68114
    - Clinical Trial Site
- Nevada
  - Las Vegas, Nevada, United States, 89121
    - Clinical Trial Site
- New Hampshire
  - Portsmouth, New Hampshire, United States, 03801
    - Clinical Trial Site
- New Jersey
  - Berlin, New Jersey, United States, 08009
    - Clinical Trial Site
- New Mexico
  - Albuquerque, New Mexico, United States, 87109
    - Clinical Trial Site
- New York
  - New York, New York, United States, 10017
    - Clinical Trial Site
- North Carolina
  - Charlotte, North Carolina, United States, 28287
    - Clinical Trial Site
  - Durham, North Carolina, United States, 27704
    - Clinical Trial Site
  - Durham, North Carolina, United States, 27713
    - Clinical Trial Site
  - Greensboro, North Carolina, United States, 27401
    - Clinical Trial Site
  - Greenville, North Carolina, United States, 27834
    - Clinical Trial Site
  - Monroe, North Carolina, United States, 28112
    - Clinical Trial Site
  - Raleigh, North Carolina, United States, 27609
    - Clinical Trial Site
  - Wilmington, North Carolina, United States, 28403
    - Clinical Trial Site
  - Winston-Salem, North Carolina, United States, 27103
    - Clinical Trial Site
- Ohio
  - Cleveland, Ohio, United States, 44106
    - Clinical Trial Site
  - Marion, Ohio, United States, 43302
    - Clinical Trial Site
- Oklahoma
  - Norman, Oklahoma, United States, 73072
    - Clinical Trial Site
  - Oklahoma City, Oklahoma, United States, 73102
    - Clinical Trial Site
- Pennsylvania
  - Bethlehem, Pennsylvania, United States, 18017
    - Clinical Trial Site
  - Langhorne, Pennsylvania, United States, 19047
    - Clinical Trial Site
  - Newport, Pennsylvania, United States, 17074
    - Clinical Trial Site
  - Philadelphia, Pennsylvania, United States, 19114
    - Clinical Trial Site
- Rhode Island
  - East Providence, Rhode Island, United States, 02914
    - Clinical Trial Site
- South Carolina
  - Myrtle Beach, South Carolina, United States, 29572
    - Clinical Trial Site
- South Dakota
  - Rapid City, South Dakota, United States, 57701
    - Clinical Trial Site
- Tennessee
  - Chattanooga, Tennessee, United States, 37404
    - Clinical Trial Site
  - Germantown, Tennessee, United States, 38138
    - Clinical Trial Site
  - Knoxville, Tennessee, United States, 37909
    - Clinical Trial Site
  - Knoxville, Tennessee, United States, 37923
    - Clinical Trial Site
  - Memphis, Tennessee, United States, 38119
    - Clinical Trial Site
- Texas
  - Austin, Texas, United States, 78744
    - Clinical Trial Site
  - Coppell, Texas, United States, 75019
    - Clinical Trial Site
  - Dallas, Texas, United States, 75234
    - Clinical Trial Site
  - Dallas, Texas, United States, 75230
    - Clinical Trial Site
  - El Paso, Texas, United States, 79925
    - Clinical Trial Site
  - El Paso, Texas, United States, 79935
    - Clinical Trial Site
  - Houston, Texas, United States, 77054
    - Clinical Trial Site
  - Houston, Texas, United States, 77081
    - Clinical Trial Site
  - Houston, Texas, United States, 77002
    - Clinical Trial Site
  - Houston, Texas, United States, 77024
    - Clinical Trial Site
  - Houston, Texas, United States, 77099
    - Clinical Trial Site
  - Magnolia, Texas, United States, 77355
    - Clinical Trial Site
  - San Antonio, Texas, United States, 78229
    - Clinical Trial Site
  - San Antonio, Texas, United States, 78240
    - Clinical Trial Site
  - Shenandoah, Texas, United States, 77384
    - Clinical Trial Site
  - Sherman, Texas, United States, 75092
    - Clinical Trial Site
  - Stephenville, Texas, United States, 76401
    - Clinical Trial Site
  - Tomball, Texas, United States, 77375
    - Clinical Trial Site
- Vermont
  - Burlington, Vermont, United States, 05401
    - Clinical Trial Site
- Virginia
  - Burke, Virginia, United States, 22015
    - Clinical Trial Site
  - Manassas, Virginia, United States, 20109
    - Clinical Trial Site
  - Norfolk, Virginia, United States, 23504
    - Clinical Trial Site
- Wisconsin
  - West Allis, Wisconsin, United States, 53227
    - Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

History of cardiovascular (CV) disease, high CV risk, or estimated glomerular filtration rate (eGFR) ≥30 to <60 mL/min/1.73m^2
Mean seated office SBP ≥140 mmHg and ≤170 mmHg
24-hour mean SBP ≥130 mmHg and ≤170 mmHg assessed by ABPM
Must be on stable therapy with 2 to 4 classes of antihypertensive medications

Exclusion Criteria:

Secondary hypertension
Orthostatic hypotension
Proteinuria >3 g/day
Serum potassium >4.8 milliequivalents per liter (mEq/L)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zilebesiran Participants will receive zilebesiran on Day 1 of the 6-month double-blind (DB) treatment period. Participants must be on stable doses of at least 2, but not more than 4, antihypertensive medications for at least 30 days prior to screening and plan to remain on stable doses of these medications during screening and through the DB treatment period.	Drug: Zilebesiran Zilebesiran administered by subcutaneous (SC) injection Other Names: ALN-AGT01
Placebo Comparator: Placebo Participants will receive placebo on Day 1 of the 6-month DB treatment period. Participants must be on stable doses of at least 2, but not more than 4, antihypertensive medications for at least 30 days prior to screening and plan to remain on stable doses of these medications during screening and through the DB treatment period.	Drug: Placebo Placebo administered by SC injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline at Month 3 in Mean Seated Office Systolic Blood Pressure (SBP) Time Frame: Baseline and Month 3	Baseline and Month 3

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline at Month 3 in 24-Hour Mean SBP Assessed by Ambulatory Blood Pressure Monitoring (ABPM) Time Frame: Baseline and Month 3	Baseline and Month 3
Change from Baseline at Month 6 in Mean Seated Office SBP Time Frame: Baseline and Month 6	Baseline and Month 6
Change from Baseline at Month 6 in 24-Hour Mean SBP Assessed by ABPM Time Frame: Baseline and Month 6	Baseline and Month 6
Proportion of Patients with Mean Seated Office SBP <140 mmHg and/or Reduction ≥10 mmHg without Intensification of Antihypertensive Regimen at Month 6 Time Frame: Month 6	Month 6
Proportion of Patients with 24-hour Mean SBP assessed by ABPM <130 mmHg and/or Reduction ≥10 mmHg without Intensification of Antihypertensive Regimen at Month 6 Time Frame: Month 6	Month 6
Change from Baseline at Month 3 and Month 6 in Daytime and Nighttime Mean SBP and Diastolic Blood Pressure (DBP) assessed by ABPM Time Frame: Baseline and Months 3 and 6	Baseline and Months 3 and 6
Change from Baseline at Month 3 and Month 6 in Mean Seated Office DBP Time Frame: Baseline and Months 3 and 6	Baseline and Months 3 and 6
Change from Baseline at Month 3 and Month 6 in 24-hour Mean DBP Assessed by ABPM Time Frame: Baseline and Months 3 and 6	Baseline and Months 3 and 6
Change from Baseline Over Time in Serum Angiotensinogen (AGT) Time Frame: Baseline through Month 6	Baseline through Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alnylam Pharmaceuticals

Investigators

Study Director: Medical Director, Alnylam Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 29, 2024

Primary Completion (Actual)

June 19, 2025

Study Completion (Actual)

December 1, 2025

Study Registration Dates

First Submitted

February 15, 2024

First Submitted That Met QC Criteria

February 15, 2024

First Posted (Actual)

February 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

ALN-AGT01-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Access to Anonymized individual participant data that support these results is made available 12 months after study completion and not less than 12 months after the product and indication have been approved in the US and/or the EU.

Access to data may be declined where there is likelihood a patient could be identified or other feasibility issue, where there is a potential conflict of interest, a planned business activities or an actual or potential competitive risk. Data will be provided contingent upon the approval of a research proposal and the execution of a data sharing agreement. Timeframes for data access may vary and can take up to 6 months or more.

Requests for access to data can be submitted via the website www.vivli.org. Questions can also be directed to datasharing@alnylam.com.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Zilebesiran as Add-on Therapy in Patients With High Cardiovascular Risk and Hypertension Not Adequately Controlled by Standard of Care Antihypertensive Medications (KARDIA-3) (KARDIA-3)

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Zilebesiran Used as Add-on Therapy in Adult Patients With High Cardiovascular Risk and Hypertension Not Adequately Controlled by Standard of Care Antihypertensive Medications

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Hypertension

Clinical Trials on Placebo

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

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CROs in Singapore

Conditions

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Sponsor/Collaborators

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