Primary HypertensionPhase 2NCT02194465
A Study of LY2623091 in Participants With High Blood Pressure
A Phase 2 study testing LY2623091, Tadalafil and Spironolactone in people with Primary Hypertension, run by Eli Lilly and Company at 43 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Hypertension
- What is being tested?
- LY2623091, Tadalafil and Spironolactone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 304 participants
- Where
- 43 sitesin 3 countries
- Study dates
- Aug 2014to Mar 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
43 sites in 3 countries.
43 sites in 3 countries
United States33 sites
Northwest Heart Clinical Research, LLC
Arlington Heights, Illinois, 60005
Maine Research Associates
Auburn, Maine, 04210
Texas Diabetes and Endocrinology
Austin, Texas, 78731-4309
Tekton Research, Inc
Austin, Texas, 78745
Northwest Clinical Research Center
Bellevue, Washington, 98007-4209
Grace Research
Bossier City, Louisiana, 71111
Metrolina Internal Medicine, P.A.
Charlotte, North Carolina, 28204
Cedar-Crosse Research Center
Chicago, Illinois, 60607
Sterling Research Group, LTD
Cincinnati, Ohio, 45219
Rapid Medical Research Inc
Cleveland, Ohio, 44122
Columbus Clinical Research
Columbus, Ohio, 43213
John Muir Health Network - The Osteoporosis Center
Concord, California, 94520
Dayton Clinical Research
Dayton, Ohio, 45406
Avail Clinical Research LLC
DeLand, Florida, 32720
Encompass Clinical Research
Encinitas, California, 92024
Lillestol Research LLC
Fargo, North Dakota, 58103
Alan Graff, MD, PA
Fort Lauderdale, Florida, 33308
Clinical Research Advantage
Glendale, Arizona, 85306
PharmQuest
Greensboro, North Carolina, 27408
Mountain View Clinical Research, Inc
Greer, South Carolina, 29651
East West Medical Institute
Honolulu, Hawaii, 96814
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 83404
Midwest Institute for Clinical Research
Indianapolis, Indiana, 46260
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
AB Clinical Trials
Las Vegas, Nevada, 89119
Community Clinical Research Center
Muncie, Indiana, 47304
Cor Clinical Research LLC
Oklahoma City, Oklahoma, 4052728481
Oklahoma Foundation For Cardiovascular Research
Oklahoma City, Oklahoma, 73120
Rochester Clinical Research, Inc.
Rochester, New York, 14609
Texas Diabetes and Endocrinology, P.A.
Round Rock, Texas, 78681
Cardiovascular Center of Sarasota
Sarasota, Florida, 34239
Universal Research Group, LLC
Tacoma, Washington, 98405
Heartland Research Associates
Wichita, Kansas, 67207
Canada8 sites
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
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
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
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
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
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
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
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
Puerto Rico2 sites
Research and Cardiovascular Corp.
Ponce, 00717-1322
Clinical Research Puerto Rico, Inc.
San Juan, 00909
About this study
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
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.
- Conditions
- Primary Hypertension
- Being tested
- LY2623091, Tadalafil, Spironolactone, Placebo
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2623091Drug
Also called Mineralocorticoid Receptor Antagonist
Administered orally
TadalafilDrug
Also called LY450190
Administered orally
SpironolactoneDrug
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| 6 milligrams (mg) LY2623091 | Experimental | 6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. Receives: Drug: LY2623091; Drug: Placebo |
| 13 mg LY2623091 | Experimental | 13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. Receives: Drug: LY2623091; Drug: Placebo |
| 24.5 mg LY2623091 | Experimental | 24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. Receives: Drug: LY2623091; Drug: Placebo |
| 13 mg LY2623091 + 20 mg tadalafil | Experimental | 13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks. Receives: Drug: LY2623091; Drug: Tadalafil; Drug: Placebo |
| 20 mg tadalafil | Experimental | 20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks. Receives: Drug: Tadalafil; Drug: Placebo |
| Spironolactone | Active comparator | 25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks. Receives: Drug: Spironolactone |
| Placebo | Placebo comparator | Placebo for blinding administered orally once daily for 4 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 Weeks
Secondary outcomes (4)
Change From Baseline to 4 Weeks in Seated Diastolic Blood Pressure (DBP)
Change from baseline in DBP as measured by a cuff. LS mean change from baseline was calculated using a MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Measured: Baseline, 4 Weeks
Change From Baseline to 4 Weeks in 24 Hour Ambulatory Blood Pressure Monitoring (ABPM)
The LS mean change in blood pressure is calculated after adjusting for baseline, treatment and race using an analysis of covariance (ANCOVA).
Measured: Baseline, 4 Weeks
Change From Baseline to 4 Weeks in Serum Potassium
Potassium measurement as measured by standard laboratory tests. The LS mean change in potassium is calculated using MMRM with adjustment for baseline, treatment, visit, treatment*visit and race.
Measured: Baseline, 4 Weeks
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2623091
Measured: 2 hours post-dose at 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Primary HypertensionStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02194465
- Sponsor's protocol ID
- 15525
- Other IDs
- I7T-MC-RMAH
- Status last verified
- Jun 2020
- First submitted
- 17 Jul 2014
- Last updated
- 26 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02194465
- Acronym / sponsor ID
- 15525
- Conditions
- Primary Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 18 Jul 2014 (estimated)
- Results
- Posted 26 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 6 milligrams (mg) LY2623091 | Experimental | Drug: LY2623091, Drug: Placebo6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. |
| 13 mg LY2623091 | Experimental | Drug: LY2623091, Drug: Placebo13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. |
| 24.5 mg LY2623091 | Experimental | Drug: LY2623091, Drug: Placebo24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. |
| 13 mg LY2623091 + 20 mg tadalafil | Experimental | Drug: LY2623091, Drug: Tadalafil, Drug: Placebo13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks. |
| 20 mg tadalafil | Experimental | Drug: Tadalafil, Drug: Placebo20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks. |
| Spironolactone | Active comparator | Drug: Spironolactone25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo for blinding administered orally once daily for 4 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- If participants are currently being treated for hypertension:
- Have a body mass index (BMI) ≥18.5 and <40 kilograms/m^2.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY2623091Also: Mineralocorticoid Receptor AntagonistAdministered orally | Drug | 13 mg LY2623091, 13 mg LY2623091 + 20 mg tadalafil, 24.5 mg LY2623091, 6 milligrams (mg) LY2623091 |
| TadalafilAlso: LY450190Administered orally | Drug | 13 mg LY2623091 + 20 mg tadalafil, 20 mg tadalafil |
| SpironolactoneAdministered orally | Drug | Spironolactone |
| PlaceboAdministered orally | Drug | 13 mg LY2623091, 13 mg LY2623091 + 20 mg tadalafil, 20 mg tadalafil, 24.5 mg LY2623091, 6 milligrams (mg) LY2623091, Placebo |
Primary outcome
Change From Baseline to 4 Weeks in Seated Systolic Blood Pressure (SBP)
Time frame: Baseline, 4 Weeks
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.
4 secondary outcomes
Change From Baseline to 4 Weeks in Seated Diastolic Blood Pressure (DBP)
Time frame: Baseline, 4 Weeks
Change From Baseline to 4 Weeks in 24 Hour Ambulatory Blood Pressure Monitoring (ABPM)
Time frame: Baseline, 4 Weeks
Change From Baseline to 4 Weeks in Serum Potassium
Time frame: Baseline, 4 Weeks
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2623091
Time frame: 2 hours post-dose at 4 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
43 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LY2623091, Tadalafil and Spironolactone in people with Primary Hypertension, run by Eli Lilly and Company at 43 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to 4 Weeks in Seated Systolic Blood Pressure (SBP) (time frame: Baseline, 4 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2020.