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Trial record 91 of 112 for:    EPLERENONE

A Study of LY2623091 in Male and Females With Chronic Kidney Disease

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: NCT01427972
Recruitment Status : Completed
First Posted : September 2, 2011
Results First Posted : June 3, 2019
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Kidney Disease
Interventions Drug: LY2623091
Drug: Eplerenone
Enrollment 42
Recruitment Details  
Pre-assignment Details Participants (pts) were randomized to 1 of 4 arms, 3 LY2623091 (LY) and Eplerenone (Epl). Each participated in two 21-day treatment periods with washout period of at least 28 days. Pts who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Pts who received Epl in Period 1 were randomized to an LY arm in Period 2.
Arm/Group Title 1.5 mg LY2623091 First Then 10 mg LY2623091 1.5 mg LY2623091 First Then 50 mg Eplerenone 1.5 mg LY2623091 First Then 0.2 mg LY2623091 50mg Eplerenone First Then 0.2 mg LY2623091 50mg Eplerenone First Then 1.5 mg LY2623091 50mg Eplerenone First Then 10 mg LY2623091 0.2 mg LY2623091 First Then 10 mg LY2623091 0.2 mg LY2623091 First Then 50 mg Eplerenone 0.2 mg LY2623091 First Then 1.5 mg LY2623091 10mg LY2623091 First Then 50mg Eplerenone 10mg LY2623091 First Then 0.2 mg LY2623091 10 mg LY2623091 First Then 1.5 mg LY2623091
Hide Arm/Group Description Participants received 1.5 milligram (mg) LY2623091 administered orally, once daily (QD) for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 10 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state. Participants received 1.5 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 50 mg Eplerenone for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state. Participants received 1.5 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 0.2 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state. Participants received 50 mg Eplerenone administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 0.2 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state. Participants received 50 mg Eplerenone administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 1.5 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state. Participants received 50 mg Eplerenone administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 10 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state. Participants received 0.2 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 10 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state. Participants received 0.2 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 50 mg Eplerenone for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state. Participants received 0.2 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 1.5 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state. Participants received 10 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 50 mg Eplerenone for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state. Participants received 10 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 0.2 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state. Participants received 10 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 1.5 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.
Period Title: Treatment Period 1 (21 Days)
Started 3 4 4 3 4 3 3 5 3 3 3 4
Received at Least 1 Dose of Study Drug 3 4 4 3 4 3 3 5 3 3 3 4
Completed 3 4 4 3 4 3 3 4 3 3 3 4
Not Completed 0 0 0 0 0 0 0 1 0 0 0 0
Reason Not Completed
Protocol Violation             0             0             0             0             0             0             0             1             0             0             0             0
Period Title: Washout (at Least 28 Days)
Started 3 4 4 3 4 3 3 4 3 3 3 4
Completed 3 4 4 3 4 1 3 4 3 3 3 4
Not Completed 0 0 0 0 0 2 0 0 0 0 0 0
Reason Not Completed
Withdrawal by Subject             0             0             0             0             0             2             0             0             0             0             0             0
Period Title: Treatment Period 2 (21 Days)
Started 3 4 4 3 4 1 3 4 3 3 3 4
Completed 3 3 4 3 4 1 3 4 3 3 3 4
Not Completed 0 1 0 0 0 0 0 0 0 0 0 0
Reason Not Completed
Withdrawal by Subject             0             1             0             0             0             0             0             0             0             0             0             0
Arm/Group Title 1.5 mg LY2623091 First Then 10 mg LY2623091 1.5 mg LY2623091 First Then 50 mg Eplerenone 1.5 mg LY2623091 First Then 0.2 mg LY2623091 50mg Eplerenone First Then 0.2 mg LY2623091 50mg Eplerenone First Then 1.5 mg LY2623091 50mg Eplerenone First Then 10 mg LY2623091 0.2 mg LY2623091 First Then 10 mg LY2623091 0.2 mg LY2623091 First Then 50 mg Eplerenone 0.2 mg LY2623091 First Then 1.5 mg LY2623091 10mg LY2623091 First Then 50mg Eplerenone 10mg LY2623091 First Then 0.2 mg LY2623091 10 mg LY2623091 First Then 1.5 mg LY2623091 Total
Hide Arm/Group Description Participants received 1.5 milligram (mg) LY2623091 administered orally, once daily (QD) for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 10 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state. Participants received 1.5 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 50 mg Eplerenone for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state. Participants received 1.5 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 0.2 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state. Participants received 50 mg Eplerenone administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 0.2 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state. Participants received 50 mg Eplerenone administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 1.5 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state. Participants received 50 mg Eplerenone administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 10 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state. Participants received 0.2 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 10 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state. Participants received 0.2 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 50 mg Eplerenone for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state. Participants received 0.2 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 1.5 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state. Participants received 10 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 50 mg Eplerenone for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state. Participants received 10 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 0.2 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state. Participants received 10 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 1.5 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state. Total of all reporting groups
Overall Number of Baseline Participants 3 4 4 3 4 3 3 5 3 3 3 4 42
Hide Baseline Analysis Population Description
All randomized participants who received study drug.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 4 participants 4 participants 3 participants 4 participants 3 participants 3 participants 5 participants 3 participants 3 participants 3 participants 4 participants 42 participants
<=18 years 0 0 0 0 0 0 0 0 0 0 0 0 0
Between 18 and 65 years 3 3 4 2 4 3 2 5 2 3 2 4 37
>=65 years 0 1 0 1 0 0 1 0 1 0 1 0 5
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 4 participants 4 participants 3 participants 4 participants 3 participants 3 participants 5 participants 3 participants 3 participants 3 participants 4 participants 42 participants
Female 2 2 0 0 2 2 1 3 2 0 1 2 17
Male 1 2 4 3 2 1 2 2 1 3 2 2 25
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 4 participants 4 participants 3 participants 4 participants 3 participants 3 participants 5 participants 3 participants 3 participants 3 participants 4 participants 42 participants
Caucasian 3 2 4 3 3 3 3 4 1 2 3 3 34
Black/African American 0 0 0 0 1 0 0 0 2 1 0 0 4
Mixed 0 2 0 0 0 0 0 1 0 0 0 1 4
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 4 participants 4 participants 3 participants 4 participants 3 participants 3 participants 5 participants 3 participants 3 participants 3 participants 4 participants 42 participants
Bulgaria 2 2 2 2 2 1 1 3 0 1 1 3 20
South Africa 1 2 1 1 2 2 2 2 3 2 2 1 21
Macedonia 0 0 1 0 0 0 0 0 0 0 0 0 1
1.Primary Outcome
Title Change From Baseline to Day 21 in Proteinuria Based on 24-hours Pooled Urine
Hide Description Proteinuria was the presence of excess serum protein in the urine. Proteinuria was calculated for each participant after each treatment period. Change was calculated as (Day 21 post-treatment value) minus (baseline value).
Time Frame Over 24 hours at Baseline and on Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received any study drug and had proteinuria values. Participants were analyzed based on the treatment they received.
Arm/Group Title 0.2 mg LY2623091 1.5 mg LY2623091 10 mg LY2623091 50 mg Eplerenone
Hide Arm/Group Description:
0.2 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 0.2 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.
1.5 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 1.5 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.
10 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 10 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.
50 mg Eplerenone capsules were administered to participants in either Period 1 or Period 2. In each period 50 mg Eplerenone was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.
Overall Number of Participants Analyzed 20 22 17 21
Mean (Standard Deviation)
Unit of Measure: milligrams/24 hours (mg/24 h)
-98.9  (1450.56) -19.7  (876.85) 119.4  (1923.11) 273.7  (1280.34)
2.Secondary Outcome
Title Change From Baseline to Day 21 in Potassium Clearance Following an Oral Potassium Challenge
Hide Description Urine potassium clearance is defined as the amount of renal potassium excreted per volume of urine from participant's pooled urine. The oral potassium challenge consisted of 35 milliequivalents (mEq) potassium administered over 10 minutes as a flavored potassium chloride solution. Change was calculated as (Day 21 values) minus (baseline values).
Time Frame Over 0-6 hours at Baseline and on Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received any study drug and had potassium clearance values. Participants were analyzed based on the treatment they received.
Arm/Group Title 0.2 mg LY2623091 1.5 mg LY2623091 10 mg LY2623091 50 mg Eplerenone
Hide Arm/Group Description:
0.2 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 0.2 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.
1.5 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 1.5 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.
10 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 10 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.
50 mg Eplerenone capsules were administered to participants in either Period 1 or Period 2. In each period 50 mg Eplerenone was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.
Overall Number of Participants Analyzed 10 10 8 8
Mean (Standard Deviation)
Unit of Measure: Hour*millimoles per liter (h*mmol/L)
0.097  (0.263) -0.122  (0.393) -0.174  (0.243) -0.019  (0.245)
3.Secondary Outcome
Title Pharmacokinetics (PK): Area Under the Plasma Concentration Time Curve During the Dosing Period of LY2623091 (AUC0-τ)
Hide Description [Not Specified]
Time Frame Predose, 1, 2, 4, 8, 12, and 24 hours postdose on Day 20 of Treatment Periods 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received LY2623091 and had AUC0-τ values. Participants were analyzed based on the treatment they received.
Arm/Group Title 0.2 mg LY2623091 1.5 mg LY2623091 10 mg LY2623091
Hide Arm/Group Description:
0.2 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 0.2 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.
1.5 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 1.5 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.
10 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 10 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.
Overall Number of Participants Analyzed 20 22 17
Mean (Standard Deviation)
Unit of Measure: hours*nanogram/milliliter (h*ng/mL)
75.321  (31.927) 526.640  (177.834) 3096.658  (1448.414)
4.Secondary Outcome
Title PK: Maximum Plasma Concentration (Cmax) of LY2623091
Hide Description [Not Specified]
Time Frame Predose, 1, 2, 4, 8, 12, and 24 hours postdose on Day 20 of Treatment Periods 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received LY2623091and had Cmax values. Participants were analyzed based on the treatment they received.
Arm/Group Title 0.2 mg LY2623091 1.5 mg LY2623091 10 mg LY2623091
Hide Arm/Group Description:
0.2 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 0.2 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.
1.5 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 1.5 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.
10 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 10 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.
Overall Number of Participants Analyzed 20 22 17
Mean (Standard Deviation)
Unit of Measure: nanograms/milliliter (ng/mL)
4.540  (2.003) 31.722  (10.325) 187.441  (87.858)
5.Other Pre-specified Outcome
Title The Number of Participants Who Died While on Study
Hide Description [Not Specified]
Time Frame Baseline up to end of Treatment Period 2 plus 10-day follow-up (80 days)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug.
Arm/Group Title 0.2 mg LY2623091 1.5 mg LY2623091 10 mg LY2623091 50 mg Eplerenone
Hide Arm/Group Description:
0.2 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 0.2 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.
1.5 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 1.5 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.
10 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 10 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.
50 mg Eplerenone capsules were administered to participants in either Period 1 or Period 2. In each period 50 mg Eplerenone was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.
Overall Number of Participants Analyzed 21 22 17 21
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   4.5%
0
   0.0%
0
   0.0%
Time Frame [Not Specified]
Adverse Event Reporting Description Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
 
Arm/Group Title 0.2 mg LY2623091 1.5 mg LY2623091 10 mg LY2623091 50 mg Eplerenone
Hide Arm/Group Description 0.2 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 0.2 mg LY2623091 was administered orally, QD for 21 days, on Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. Participants went through a minimum 28-day Washout Period between Period 1 and Period 2. 1.5 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 1.5 mg LY2623091 was administered orally, QD for 21 days, on Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. Participants went through a minimum 28-day Washout Period between Period 1 and Period 2. 10 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 10 mg LY2623091 was administered orally, QD for 21 days, on Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. Participants went through a minimum 28-day Washout Period between Period 1 and Period 2. 50 mg Eplerenone capsules were administered to participants in either Period 1 or Period 2. In each period 50 mg Eplerenone was administered orally, QD for 21 days, on Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. Participants went through a minimum 28-day Washout Period between Period 1 and Period 2.
All-Cause Mortality
0.2 mg LY2623091 1.5 mg LY2623091 10 mg LY2623091 50 mg Eplerenone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
0.2 mg LY2623091 1.5 mg LY2623091 10 mg LY2623091 50 mg Eplerenone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/21 (0.00%)      1/22 (4.55%)      0/17 (0.00%)      1/21 (4.76%)    
Injury, poisoning and procedural complications         
Toxicity to various agents  1  0/21 (0.00%)  0 0/22 (0.00%)  0 0/17 (0.00%)  0 1/21 (4.76%)  1
Nervous system disorders         
Cerebrovascular accident  1  0/21 (0.00%)  0 1/22 (4.55%)  1 0/17 (0.00%)  0 0/21 (0.00%)  0
Vascular disorders         
Arterial insufficiency  1  0/21 (0.00%)  0 0/22 (0.00%)  0 0/17 (0.00%)  0 1/21 (4.76%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
0.2 mg LY2623091 1.5 mg LY2623091 10 mg LY2623091 50 mg Eplerenone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/21 (42.86%)      8/22 (36.36%)      8/17 (47.06%)      10/21 (47.62%)    
Eye disorders         
Conjunctivitis  1  1/21 (4.76%)  1 0/22 (0.00%)  0 0/17 (0.00%)  0 0/21 (0.00%)  0
Eye pain  1  0/21 (0.00%)  0 1/22 (4.55%)  1 0/17 (0.00%)  0 0/21 (0.00%)  0
Uveitis  1  1/21 (4.76%)  1 0/22 (0.00%)  0 0/17 (0.00%)  0 0/21 (0.00%)  0
Gastrointestinal disorders         
Abdominal discomfort  1  0/21 (0.00%)  0 0/22 (0.00%)  0 1/17 (5.88%)  1 0/21 (0.00%)  0
Abdominal pain  1  1/21 (4.76%)  1 0/22 (0.00%)  0 0/17 (0.00%)  0 0/21 (0.00%)  0
Abdominal pain upper  1  1/21 (4.76%)  1 0/22 (0.00%)  0 0/17 (0.00%)  0 0/21 (0.00%)  0
Constipation  1  0/21 (0.00%)  0 0/22 (0.00%)  0 1/17 (5.88%)  1 0/21 (0.00%)  0
Diarrhoea  1  1/21 (4.76%)  1 2/22 (9.09%)  2 1/17 (5.88%)  1 0/21 (0.00%)  0
Dyspepsia  1  0/21 (0.00%)  0 1/22 (4.55%)  1 0/17 (0.00%)  0 0/21 (0.00%)  0
Hypoaesthesia oral  1  1/21 (4.76%)  2 0/22 (0.00%)  0 0/17 (0.00%)  0 0/21 (0.00%)  0
Lip blister  1  0/21 (0.00%)  0 0/22 (0.00%)  0 0/17 (0.00%)  0 1/21 (4.76%)  1
Nausea  1  2/21 (9.52%)  2 0/22 (0.00%)  0 1/17 (5.88%)  1 1/21 (4.76%)  1
Vomiting  1  1/21 (4.76%)  1 0/22 (0.00%)  0 1/17 (5.88%)  1 1/21 (4.76%)  1
General disorders         
Fatigue  1  1/21 (4.76%)  1 0/22 (0.00%)  0 0/17 (0.00%)  0 0/21 (0.00%)  0
Pyrexia  1  0/21 (0.00%)  0 0/22 (0.00%)  0 0/17 (0.00%)  0 1/21 (4.76%)  2
Infections and infestations         
Dacryocystitis  1  1/21 (4.76%)  1 0/22 (0.00%)  0 0/17 (0.00%)  0 0/21 (0.00%)  0
Influenza  1  1/21 (4.76%)  1 0/22 (0.00%)  0 0/17 (0.00%)  0 0/21 (0.00%)  0
Kidney infection  1  1/21 (4.76%)  1 0/22 (0.00%)  0 0/17 (0.00%)  0 0/21 (0.00%)  0
Nasopharyngitis  1  1/21 (4.76%)  1 1/22 (4.55%)  1 0/17 (0.00%)  0 1/21 (4.76%)  1
Rhinitis  1  0/21 (0.00%)  0 1/22 (4.55%)  1 0/17 (0.00%)  0 0/21 (0.00%)  0
Urinary tract infection  1  1/21 (4.76%)  1 0/22 (0.00%)  0 0/17 (0.00%)  0 0/21 (0.00%)  0
Injury, poisoning and procedural complications         
Overdose  1  0/21 (0.00%)  0 0/22 (0.00%)  0 1/17 (5.88%)  1 0/21 (0.00%)  0
Tooth fracture  1  0/21 (0.00%)  0 1/22 (4.55%)  1 0/17 (0.00%)  0 0/21 (0.00%)  0
Investigations         
Blood creatine phosphokinase increased  1  1/21 (4.76%)  1 0/22 (0.00%)  0 0/17 (0.00%)  0 0/21 (0.00%)  0
Blood potassium increased  1  0/21 (0.00%)  0 0/22 (0.00%)  0 1/17 (5.88%)  1 0/21 (0.00%)  0
Haemoglobin decreased  1  0/21 (0.00%)  0 1/22 (4.55%)  1 0/17 (0.00%)  0 0/21 (0.00%)  0
Metabolism and nutrition disorders         
Hypoglycaemia  1  1/21 (4.76%)  1 0/22 (0.00%)  0 1/17 (5.88%)  1 2/21 (9.52%)  3
Hyponatraemia  1  1/21 (4.76%)  1 0/22 (0.00%)  0 0/17 (0.00%)  0 0/21 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Back pain  1  0/21 (0.00%)  0 0/22 (0.00%)  0 1/17 (5.88%)  1 0/21 (0.00%)  0
Muscle spasms  1  0/21 (0.00%)  0 1/22 (4.55%)  1 1/17 (5.88%)  1 1/21 (4.76%)  1
Myalgia  1  0/21 (0.00%)  0 0/22 (0.00%)  0 1/17 (5.88%)  1 1/21 (4.76%)  1
Nervous system disorders         
Dizziness  1  1/21 (4.76%)  1 1/22 (4.55%)  1 0/17 (0.00%)  0 0/21 (0.00%)  0
Headache  1  1/21 (4.76%)  1 1/22 (4.55%)  1 1/17 (5.88%)  2 0/21 (0.00%)  0
Paraesthesia  1  0/21 (0.00%)  0 0/22 (0.00%)  0 1/17 (5.88%)  1 0/21 (0.00%)  0
Psychiatric disorders         
Insomnia  1  0/21 (0.00%)  0 1/22 (4.55%)  1 0/17 (0.00%)  0 0/21 (0.00%)  0
Vascular disorders         
Arterial insufficiency  1  0/21 (0.00%)  0 0/22 (0.00%)  0 0/17 (0.00%)  0 1/21 (4.76%)  1
Haematoma  1  0/21 (0.00%)  0 0/22 (0.00%)  0 1/17 (5.88%)  1 0/21 (0.00%)  0
Hypotension  1  0/21 (0.00%)  0 0/22 (0.00%)  0 0/17 (0.00%)  0 1/21 (4.76%)  1
Orthostatic hypotension  1  0/21 (0.00%)  0 0/22 (0.00%)  0 0/17 (0.00%)  0 1/21 (4.76%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01427972     History of Changes
Other Study ID Numbers: 14350
I4M-MC-MRAC ( Other Identifier: Eli Lilly and Company )
First Submitted: August 31, 2011
First Posted: September 2, 2011
Results First Submitted: September 27, 2017
Results First Posted: June 3, 2019
Last Update Posted: September 9, 2019