Clinical trial NCT02194465: A Study of LY2623091 in Participants With High Blood Pressure
Official title: A Randomized, Placebo-Controlled, Double-Blinded, Parallel, Phase 2a Study to Evaluate the Safety and Efficacy of LY2623091 in Patients With Primary Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Hypertension
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2014-07-18
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as LY2623091 in participants with high blood pressure.


Eligibility criteria: Inclusion Criteria:

* Have a history of hypertension.
* If participants are naïve to treatment of hypertension, or have not been treated with any antihypertensive medications within the 30 days immediately prior to screening:

  * Have seated systolic (SBP) of ≥140 and \<170 millimeters of mercury (mmHg) at screening and at the end of the lead-in period.
* If participants are currently being treated for hypertension:

  * Are taking a stable dose of 1 or 2 antihypertensive medications for at least the previous 30 days. A combination antihypertensive medication from 2 classes is considered as 2 antihypertensive medications.
  * Are willing to discontinue the antihypertensive medications during the study.
  * Have seated SBP of ≥140 and \<170 mmHg at the end of the lead-in period.
* Have a body mass index (BMI) ≥18.5 and \<40 kilograms/m\^2.

Exclusion Criteria:

* Have a history of severe hypertension (defined as SBP ≥180 mmHg and/or diastolic (DBP) ≥120 mmHg), secondary hypertension, symptomatic postural hypotension, or hospitalization due to hypertension.
* Have SBP ≥180 mmHg and/or DBP ≥110 mmHg at screening, lead-in period, or randomization.
* Have a history of hospitalization due to hyperkalemia, or history of drug discontinuation due to elevated serum potassium levels.
* Have a serum potassium ≤3.5 or \>5.0 millimoles per liter (mmol/L).
* Have an estimated glomerular filtration rate (eGFR) \<50 milliliters/minute/1.73 m\^2.

Primary outcomes:
measure: Change From Baseline to 4 Weeks in Seated Systolic Blood Pressure (SBP)
timeFrame: Baseline, 4 Weeks
Secondary outcomes:
measure: Change From Baseline to 4 Weeks in Seated Diastolic Blood Pressure (DBP)
timeFrame: Baseline, 4 Weeks
measure: Change From Baseline to 4 Weeks in 24 Hour Ambulatory Blood Pressure Monitoring (ABPM)
timeFrame: Baseline, 4 Weeks
measure: Change From Baseline to 4 Weeks in Serum Potassium
timeFrame: Baseline, 4 Weeks
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2623091
timeFrame: 2 hours post-dose at 4 Weeks
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Clinical Research Advantage
state: Arizona
city: Concord
country: United States
facility: John Muir Health Network - The Osteoporosis Center
state: California
city: Encinitas
country: United States
facility: Encompass Clinical Research
state: California
city: DeLand
country: United States
facility: Avail Clinical Research LLC
state: Florida
city: Fort Lauderdale
country: United States
facility: Alan Graff, MD, PA
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Sarasota
country: United States
facility: Cardiovascular Center of Sarasota
state: Florida
city: Honolulu
country: United States
facility: East West Medical Institute
state: Hawaii
city: Idaho Falls
country: United States
facility: Rocky Mountain Diabetes and Osteoporosis Center
state: Idaho
city: Arlington Heights
country: United States
facility: Northwest Heart Clinical Research, LLC
state: Illinois
city: Chicago
country: United States
facility: Cedar-Crosse Research Center
state: Illinois
city: Indianapolis
country: United States
facility: Midwest Institute for Clinical Research
state: Indiana
city: Muncie
country: United States
facility: Community Clinical Research Center
state: Indiana
city: Wichita
country: United States
facility: Heartland Research Associates
state: Kansas
city: Bossier City
country: United States
facility: Grace Research
state: Louisiana
city: Auburn
country: United States
facility: Maine Research Associates
state: Maine
city: Las Vegas
country: United States
facility: AB Clinical Trials
state: Nevada
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Charlotte
country: United States
facility: Metrolina Internal Medicine, P.A.
state: North Carolina
city: Greensboro
country: United States
facility: PharmQuest
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research LLC
state: North Dakota
city: Cincinnati
country: United States
facility: Sterling Research Group, LTD
state: Ohio
city: Cleveland
country: United States
facility: Rapid Medical Research Inc
state: Ohio
city: Columbus
country: United States
facility: Columbus Clinical Research
state: Ohio
city: Dayton
country: United States
facility: Dayton Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Cor Clinical Research LLC
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Foundation For Cardiovascular Research
state: Oklahoma
city: Greer
country: United States
facility: Mountain View Clinical Research, Inc
state: South Carolina
city: Austin
country: United States
facility: Texas Diabetes and Endocrinology
state: Texas
city: Austin
country: United States
facility: Tekton Research, Inc
state: Texas
city: Round Rock
country: United States
facility: Texas Diabetes and Endocrinology, P.A.
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Tacoma
country: United States
facility: Universal Research Group, LLC
state: Washington
city: Brampton
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Kelowna
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Peterborough
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Pointe Claire
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Quebec City
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Red Deer
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Sherbrooke
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Toronto
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Ponce
country: Puerto Rico
facility: Research and Cardiovascular Corp.
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico, Inc.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: