A Study to Evaluate Efficacy and Safety of ALN-AGT01 in Patients With Mild To-Moderate Hypertension (KARDIA-1)
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: ALN-AGT01 Dose Regimen 1 Multiple doses of ALN-AGT01 administered by subcutaneous (SC) injection during the 12-month DB treatment period. |
Drug: ALN-AGT01
ALN-AGT01 administered by SC injection
|
Experimental: ALN-AGT01 Dose Regimen 2 Multiple doses of ALN-AGT01 administered by SC injection during the 12-month DB treatment period. |
Drug: ALN-AGT01
ALN-AGT01 administered by SC injection
|
Experimental: ALN-AGT01 Dose Regimen 3 Multiple doses of ALN-AGT01 administered by SC injection during the 12-month DB treatment period. |
Drug: ALN-AGT01
ALN-AGT01 administered by SC injection
|
Experimental: ALN-AGT01 Dose Regimen 4 Multiple doses of ALN-AGT01 administered by SC injection during the 12-month DB treatment period. |
Drug: ALN-AGT01
ALN-AGT01 administered by SC injection
|
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. |
Drug: Placebo
Placebo administered by SC injection
Drug: ALN-AGT01
ALN-AGT01 administered by SC injection
|
Outcome Measures
Primary Outcome Measures
- Change from Baseline at Month 3 in 24-hour Mean Systolic Blood Pressure (SBP) Assessed by Ambulatory Blood Pressure Monitoring (ABPM) [Baseline and Month 3]
Secondary Outcome Measures
- Change from Baseline at Months 3 and 6 in Office SBP [Baseline and Months 3 and 6]
- Change from Baseline at Month 6 in 24-hour Mean SBP Assessed by ABPM [Baseline and 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 [Baseline and Month 6]
- Time-adjusted Change from Baseline in 24-hour Mean SBP and Diastolic Blood Pressure (DBP), Assessed by ABPM [Baseline through Month 6]
- Change from Baseline in 24-hour mean DBP, Assessed by ABPM [Baseline and Month 6]
- Change from Baseline in Office SBP and DBP [Baseline and Month 6]
- Change in Serum Angiotensinogen (AGT [Baseline through Month 6]
- Change from Baseline in Daytime and Nighttime SBP and DBP by ABPM (Including Dipping Pattern) [Baseline and Month 6]
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Clinical Trial Site | Birmingham | Alabama | United States | 35209 |
2 | Clinical Trial Site | Glendale | Arizona | United States | 85308 |
3 | Clinical Trial Site | Tempe | Arizona | United States | 85281 |
4 | Clinical Trial Site | Tempe | Arizona | United States | 85282 |
5 | Clinical Trial Site | La Mesa | California | United States | 91942 |
6 | Clinical Trial Site | Los Angeles | California | United States | 90057 |
7 | Clinical Trial Site | Montclair | California | United States | 91763 |
8 | Clinical Trial Site | S. Gate | California | United States | 90280 |
9 | Clinical Trial Site | San Diego | California | United States | 92103 |
10 | Clinical Trial Site | Vista | California | United States | 92083 |
11 | Clinical Trial Site | Clearwater | Florida | United States | 33756 |
12 | Clinical Trial Site | Coral Gables | Florida | United States | 33134 |
13 | Clinical Trial Site | Fleming Island | Florida | United States | 32003 |
14 | Clinical Trial Site | Hollywood | Florida | United States | 33024 |
15 | Clinical Trial Site | Inverness | Florida | United States | 34452 |
16 | Clinical Trial Site | Jacksonville | Florida | United States | 32204 |
17 | Clinical Trial Site | Jacksonville | Florida | United States | 32216 |
18 | Clinical Trial Site | Jacksonville | Florida | United States | 32256 |
19 | Clinical Trial Site | Miami | Florida | United States | 33126 |
20 | Clinical Trial Site | Miami | Florida | United States | 33135 |
21 | Clinical Trial Site | Naples | Florida | United States | 34102 |
22 | Clinical Trial Site | Orlando | Florida | United States | 32801 |
23 | Clinical Trial Site | Acworth | Georgia | United States | 30101 |
24 | Clinical Trial Site | Columbus | Georgia | United States | 31904 |
25 | Clinical Trial Site | Fayetteville | Georgia | United States | 30214 |
26 | Clinical Trial Site | Macon | Georgia | United States | 31210 |
27 | Clinical Trial Site | Savannah | Georgia | United States | 31406 |
28 | Clinical Trial Site | Snellville | Georgia | United States | 30078 |
29 | Clinical Trial Site | Champaign | Illinois | United States | 61822 |
30 | Clinical Trial Site | Quincy | Illinois | United States | 62301 |
31 | Clinical Trial Site | River Forest | Illinois | United States | 60305 |
32 | Clinical Trial Site | Franklin | Indiana | United States | 46131 |
33 | Clinical Trial Site | Greenfield | Indiana | United States | 46140 |
34 | Clinical Trial Site | Valparaiso | Indiana | United States | 46383 |
35 | Clinical Trial Site | West Des Moines | Iowa | United States | 50266 |
36 | Clinical Trial Site | Versailles | Kentucky | United States | 40383 |
37 | Clinical Trial Site | Lake Charles | Louisiana | United States | 70601 |
38 | Clinical Trial Site | New Orleans | Louisiana | United States | 70124 |
39 | Clinical Trial Site | Prairieville | Louisiana | United States | 70769 |
40 | Clinical Trial Site | Baltimore | Maryland | United States | 21229 |
41 | Clinical Trial Site | Jefferson City | Missouri | United States | 65109 |
42 | Clinical Trial Site | Henderson | Nevada | United States | 89052 |
43 | Clinical Trial Site | Las Vegas | Nevada | United States | 89119 |
44 | Clinical Trial Site | Berlin | New Jersey | United States | 08009 |
45 | Clinical Trial Site | Bronx | New York | United States | 10456 |
46 | Clinical Trial Site | New York | New York | United States | 10036 |
47 | Clinical Trial Site | Greensboro | North Carolina | United States | 27408 |
48 | Clinical Trial Site | Greensboro | North Carolina | United States | 27410 |
49 | Clinical Trial Site | Wilmington | North Carolina | United States | 28401 |
50 | Clinical Trial Site | Tulsa | Oklahoma | United States | 74135 |
51 | Clinical Trial Site | Medford | Oregon | United States | 97504 |
52 | Clinical Trial Site | Greenville | South Carolina | United States | 29607 |
53 | Clinical Trial Site | Rock Hill | South Carolina | United States | 29732 |
54 | Clinical Trial Site | Spartanburg | South Carolina | United States | 29303 |
55 | Clinical Trial Site | Memphis | Tennessee | United States | 38119 |
56 | Clinical Trial Site | Carrollton | Texas | United States | 75010 |
57 | Clinical Trial Site | Cedar Park | Texas | United States | 78613 |
58 | Clinical Trial Site | Dallas | Texas | United States | 75234 |
59 | Clinical Trial Site | Dallas | Texas | United States | 75251 |
60 | Clinical Trial Site | Houston | Texas | United States | 77074 |
61 | Clinical Trial Site | Houston | Texas | United States | 77081 |
62 | Clinical Trial Site | Magnolia | Texas | United States | 77355 |
63 | Clinical Trial Site | Pearland | Texas | United States | 77584 |
64 | Clinical Trial Site | San Antonio | Texas | United States | 78229 |
65 | Clinical Trial Site | Stephenville | Texas | United States | 76401 |
66 | Clinical Trial Site | Sugar Land | Texas | United States | 77478 |
67 | Clinical Trial Site | Tomball | Texas | United States | 77375 |
68 | Clinical Trial Site | Waco | Texas | United States | 76708 |
69 | Clinical Trial Site | Appomattox | Virginia | United States | 24522 |
70 | Clinical Trial Site | Burke | Virginia | United States | 22015 |
71 | Clinical Trial Site | Brampton | Ontario | Canada | |
72 | Clinical Trial Site | London | Ontario | Canada | |
73 | Clinical Trial Site | Toronto | Ontario | Canada | |
74 | Clinical Trial Site | Chicoutimi | Quebec | Canada | |
75 | Clinical Trial Site | Mirabel | Quebec | Canada | |
76 | Clinical Trial Site | Montréal | Quebec | Canada | |
77 | Clinical Trial Site | Quebec City | Quebec | Canada | |
78 | Clinical Trial Site | Trois-Rivières | Quebec | Canada | |
79 | Clinical Trial Site | Victoriaville | Quebec | Canada | |
80 | Clinical Trial Site | San Juan | Puerto Rico | ||
81 | Clinical Trial Site | Ivano-Frankivs'k | Ukraine | ||
82 | Clinical Trial Site | Kharkiv | Ukraine | ||
83 | Clinical Trial Site | Kyiv | Ukraine | ||
84 | Clinical Trial Site | Lviv | Ukraine | ||
85 | Clinical Trial Site | Odesa | Ukraine | ||
86 | Clinical Trial Site | Vinnytsia | Ukraine | ||
87 | Clinical Trial Site | Zaporizhzhia | Ukraine | ||
88 | Clinical Trial Site | Úzhgorod | Ukraine | ||
89 | Clinical Trial Site | Chorley | United Kingdom | ||
90 | Clinical Trial Site | Glasgow | United Kingdom | ||
91 | Clinical Trial Site | Hexham | United Kingdom | ||
92 | Clinical Trial Site | London | United Kingdom | ||
93 | Clinical Trial Site | Manchester | United Kingdom |
Sponsors and Collaborators
- Alnylam Pharmaceuticals
Investigators
- Study Director: Medical Director, Alnylam Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ALN-AGT01-002
- 2021-001248-82