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A Study to Evaluate Efficacy and Safety of ALN-AGT01 in Patients With Mild To-Moderate Hypertension (KARDIA-1) (KARDIA-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04936035
Recruitment Status : Active, not recruiting
First Posted : June 23, 2021
Last Update Posted : February 20, 2024
Sponsor:
Information provided by (Responsible Party):
Alnylam Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE June 14, 2021
First Posted Date  ICMJE June 23, 2021
Last Update Posted Date February 20, 2024
Actual Study Start Date  ICMJE July 7, 2021
Actual Primary Completion Date April 4, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2022)
Change from Baseline at Month 3 in 24-hour Mean Systolic Blood Pressure (SBP) Assessed by Ambulatory Blood Pressure Monitoring (ABPM) [ Time Frame: Baseline and Month 3 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 14, 2021)
Change in Systolic Blood Pressure (SBP) from Baseline to Month 3, Assessed by Ambulatory Blood Pressure Monitoring (ABPM) [ Time Frame: Baseline and Month 3 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2023)
  • Change from Baseline at Month 3 in Office SBP [ Time Frame: Baseline and Month 3 ]
  • Change from Baseline at Month 6 in 24-hour Mean SBP Assessed by ABPM [ Time Frame: Baseline through Month 6 ]
  • Change from Baseline at Month 6 in Office SBP [ Time Frame: Baseline through Month 6 ]
  • Proportion of Patients with 24-hour Mean SBP Assessed by ABPM <130 mmHg and/or Reduction ≥20 mmHg without Additional Antihypertensive Medications at Month 6 [ Time Frame: Baseline through Month 6 ]
  • Time-adjusted Change from Baseline in 24-hour Mean SBP and Diastolic Blood Pressure (DBP), Assessed by ABPM [ Time Frame: Baseline through Month 6 ]
  • Change from Baseline in 24-hour mean DBP, Assessed by ABPM [ Time Frame: Baseline through Month 6 ]
  • Change from Baseline in Office SBP and DBP [ Time Frame: Baseline through Month 6 ]
  • Change in Serum Angiotensinogen (AGT) [ Time Frame: Baseline through Month 6 ]
  • Change from Baseline in Daytime and Nighttime SBP and DBP by ABPM (Including Dipping Pattern) [ Time Frame: Baseline through Month 6 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2021)
  • Change in SBP from Baseline to Month 6, Assessed by ABPM [ Time Frame: Baseline through Month 6 ]
  • Change in Diastolic Blood Pressure (DBP) from Baseline to Month 3 and Month 6, Assessed by ABPM [ Time Frame: Baseline through Months 3 and 6 ]
  • Change in Office SBP from Baseline Through Month 6 [ Time Frame: Baseline through Month 6 ]
  • Change in Office DBP from Baseline Through Month 6 [ Time Frame: Baseline through Month 6 ]
  • Change in Serum Angiotensinogen (AGT) from Baseline Through Month 6 [ Time Frame: Baseline through Month 6 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Efficacy and Safety of ALN-AGT01 in Patients With Mild To-Moderate Hypertension (KARDIA-1)
Official Title  ICMJE A Randomized, Double-blind, Placebo-Controlled, Dose-Ranging Multicenter Study to Evaluate the Efficacy and Safety of ALN-AGT01 in Patients With Mild-to-Moderate Hypertension
Brief Summary The purpose of this study is to evaluate the effect of ALN-AGT01 on systolic and diastolic blood pressure and to characterize the pharmacodynamic (PD) effects and safety of ALN-AGT01.
Detailed Description Participants will receive ALN-AGT01 or placebo for the first 6 months of the 12-month double-blind (DB) treatment period. Participants randomized to placebo will be re-randomized at Month 6 to 1 of the 4 initial ALN-AGT01 regimens until the end of the 12-month DB treatment period. Participants randomized to ALN-AGT01 regimens will remain on their originally assigned regimens through remainder of the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: Placebo
    Placebo administered by SC injection
  • Drug: ALN-AGT01
    ALN-AGT01 administered by SC injection
Study Arms  ICMJE
  • Experimental: ALN-AGT01 Dose Regimen 1
    Multiple doses of ALN-AGT01 administered by subcutaneous (SC) injection during the 12-month DB treatment period.
    Intervention: Drug: ALN-AGT01
  • Experimental: ALN-AGT01 Dose Regimen 2
    Multiple doses of ALN-AGT01 administered by SC injection during the 12-month DB treatment period.
    Intervention: Drug: ALN-AGT01
  • Experimental: ALN-AGT01 Dose Regimen 3
    Multiple doses of ALN-AGT01 administered by SC injection during the 12-month DB treatment period.
    Intervention: Drug: ALN-AGT01
  • Experimental: ALN-AGT01 Dose Regimen 4
    Multiple doses of ALN-AGT01 administered by SC injection during the 12-month DB treatment period.
    Intervention: Drug: ALN-AGT01
  • Placebo Comparator: Placebo + ALN-AGT01
    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.
    Interventions:
    • Drug: Placebo
    • Drug: ALN-AGT01
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 2, 2023)
394
Original Estimated Enrollment  ICMJE
 (submitted: June 14, 2021)
375
Estimated Study Completion Date  ICMJE December 31, 2024
Actual Primary Completion Date April 4, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Daytime mean SBP ≥135 mmHg and ≤160 mmHg by ABPM, without antihypertensive medication

Exclusion Criteria:

  • Secondary hypertension, orthostatic hypotension
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2× upper limit of normal (ULN)
  • Elevated potassium >5 mEq/L
  • Estimated glomerular filtration rate (eGFR) of ≤30 mL/min/1.73m^2
  • Received an investigational agent within the last 30 days
  • Type 1 diabetes mellitus, poorly controlled Type 2 diabetes mellitus, newly diagnosed Type 2 diabetes mellitus
  • History of any cardiovascular event within 6 months prior to randomization
  • History of intolerance to SC injection(s)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Puerto Rico,   Ukraine,   United Kingdom,   United States
Removed Location Countries Germany
 
Administrative Information
NCT Number  ICMJE NCT04936035
Other Study ID Numbers  ICMJE ALN-AGT01-002
2021-001248-82 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Alnylam Pharmaceuticals
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Alnylam Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Alnylam Pharmaceuticals
PRS Account Alnylam Pharmaceuticals
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP