A Study of LY2623091 in Participants With High Blood Pressure
A Randomized, Placebo-Controlled, Double-Blinded, Parallel, Phase 2a Study to Evaluate the Safety and Efficacy of LY2623091 in Patients With Primary Hypertension
2 other identifiers
interventional
304
3 countries
43
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2014
Shorter than P25 for phase_2
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2014
CompletedFirst Posted
Study publicly available on registry
July 18, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
June 26, 2020
CompletedJune 26, 2020
June 1, 2020
7 months
July 17, 2014
June 9, 2020
June 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline to 4 Weeks in Seated Systolic Blood Pressure (SBP)
Change from baseline in SBP as measured by a cuff. Least squares (LS) mean change from baseline was calculated using a mixed model repeating measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Baseline, 4 Weeks
Secondary Outcomes (4)
Change From Baseline to 4 Weeks in Seated Diastolic Blood Pressure (DBP)
Baseline, 4 Weeks
Change From Baseline to 4 Weeks in 24 Hour Ambulatory Blood Pressure Monitoring (ABPM)
Baseline, 4 Weeks
Change From Baseline to 4 Weeks in Serum Potassium
Baseline, 4 Weeks
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2623091
2 hours post-dose at 4 Weeks
Study Arms (7)
6 milligrams (mg) LY2623091
EXPERIMENTAL6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
13 mg LY2623091
EXPERIMENTAL13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
24.5 mg LY2623091
EXPERIMENTAL24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
13 mg LY2623091 + 20 mg tadalafil
EXPERIMENTAL13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.
20 mg tadalafil
EXPERIMENTAL20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.
Spironolactone
ACTIVE COMPARATOR25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
Placebo
PLACEBO COMPARATORPlacebo for blinding administered orally once daily for 4 weeks.
Interventions
Administered orally
Administered orally
Administered orally
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
Clinical Research Advantage
Glendale, Arizona, 85306, United States
John Muir Health Network - The Osteoporosis Center
Concord, California, 94520, United States
Encompass Clinical Research
Encinitas, California, 92024, United States
Avail Clinical Research LLC
DeLand, Florida, 32720, United States
Alan Graff, MD, PA
Fort Lauderdale, Florida, 33308, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Cardiovascular Center of Sarasota
Sarasota, Florida, 34239, United States
East West Medical Institute
Honolulu, Hawaii, 96814, United States
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 83404, United States
Northwest Heart Clinical Research, LLC
Arlington Heights, Illinois, 60005, United States
Cedar-Crosse Research Center
Chicago, Illinois, 60607, United States
Midwest Institute for Clinical Research
Indianapolis, Indiana, 46260, United States
Community Clinical Research Center
Muncie, Indiana, 47304, United States
Heartland Research Associates
Wichita, Kansas, 67207, United States
Grace Research
Bossier City, Louisiana, 71111, United States
Maine Research Associates
Auburn, Maine, 04210, United States
AB Clinical Trials
Las Vegas, Nevada, 89119, United States
Rochester Clinical Research, Inc.
Rochester, New York, 14609, United States
Metrolina Internal Medicine, P.A.
Charlotte, North Carolina, 28204, United States
PharmQuest
Greensboro, North Carolina, 27408, United States
Lillestol Research LLC
Fargo, North Dakota, 58103, United States
Sterling Research Group, LTD
Cincinnati, Ohio, 45219, United States
Rapid Medical Research Inc
Cleveland, Ohio, 44122, United States
Columbus Clinical Research
Columbus, Ohio, 43213, United States
Dayton Clinical Research
Dayton, Ohio, 45406, United States
Cor Clinical Research LLC
Oklahoma City, Oklahoma, 4052728481, United States
Oklahoma Foundation For Cardiovascular Research
Oklahoma City, Oklahoma, 73120, United States
Mountain View Clinical Research, Inc
Greer, South Carolina, 29651, United States
Texas Diabetes and Endocrinology
Austin, Texas, 78731-4309, United States
Tekton Research, Inc
Austin, Texas, 78745, United States
Texas Diabetes and Endocrinology, P.A.
Round Rock, Texas, 78681, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007-4209, United States
Universal Research Group, LLC
Tacoma, Washington, 98405, United States
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.
Brampton, L6T 0G1, Canada
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.
Kelowna, V1Y3G8, Canada
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.
Peterborough, K9J 0B2, Canada
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.
Pointe-Claire, H9R 4S3, Canada
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.
Québec, G1N 4V3, Canada
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.
Red Deer, T4N 6V7, Canada
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.
Sherbrooke, J1J 2G2, Canada
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.
Toronto, M9W 4L6, Canada
Research and Cardiovascular Corp.
Ponce, 00717-1322, Puerto Rico
Clinical Research Puerto Rico, Inc.
San Juan, 00909, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2014
First Posted
July 18, 2014
Study Start
August 1, 2014
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
June 26, 2020
Results First Posted
June 26, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.