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Trial record 1 of 1 for:    NCT00910962
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A Study to Evaluate the Safety of 12 Weeks of Dosing With GW856553 and Its Effects on Inflammatory Markers, Infarct Size, and Cardiac Function in Subjects With Myocardial Infarction Without ST-segment Elevation (Solstice)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00910962
First Posted: June 1, 2009
Last Update Posted: December 7, 2017
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.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: August 18, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Acute Coronary Syndrome
Interventions: Drug: GW856553
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 535 participants, with myocardial infarction without ST segment elevation, were randomized to the study of which 526 participants received at least one dose of study drug. The study was conducted at 83 centers, from 08 October 2009 to 06 March 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo (P) Eligible participants received matching placebo, orally twice daily for 12 weeks.
Losmapimod 7.5 mg (A) Eligible participants received oral losmapimod 7.5 milligrams (mg) starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group).
Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B) Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group).

Participant Flow:   Overall Study
    Placebo (P)   Losmapimod 7.5 mg (A)   Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B)
STARTED   135   199   192 
COMPLETED   92   121   116 
NOT COMPLETED   43   78   76 
Adverse Event                5                20                17 
Protocol Violation                1                3                3 
Lost to Follow-up                0                3                1 
Physician Decision                0                6                6 
Withdrawal by Subject                25                32                32 
Reached defined stopping criteria                12                14                17 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The race of one participant each in treatment A and treatment B were unknown.

Reporting Groups
  Description
Placebo (P) Eligible participants received matching placebo, orally twice daily for 12 weeks.
Losmapimod 7.5 mg (A) Eligible participants received oral losmapimod 7.5 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group).
Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B) Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group).
Total Total of all reporting groups

Baseline Measures
   Placebo (P)   Losmapimod 7.5 mg (A)   Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B)   Total 
Overall Participants Analyzed 
[Units: Participants]
 135   199   192   526 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.4  (10.29)   62.6  (11.03)   64.6  (10.50)   63.5  (10.66) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      40  29.6%      52  26.1%      57  29.7%      149  28.3% 
Male      95  70.4%      147  73.9%      135  70.3%      377  71.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      3   1.5%      0   0.0%      3   0.6% 
Asian      4   3.0%      4   2.0%      9   4.7%      17   3.2% 
Native Hawaiian or Other Pacific Islander      1   0.7%      2   1.0%      3   1.6%      6   1.1% 
Black or African American      2   1.5%      6   3.0%      5   2.6%      13   2.5% 
White      128  94.8%      183  92.0%      174  90.6%      485  92.2% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      1   0.5%      1   0.5%      2   0.4% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Up to Week 14 ]

2.  Primary:   Number of Participants With Any Major Adverse Cardiovascular Events (MACE)   [ Time Frame: Up to Week 14 ]

3.  Primary:   Number of Participants With Any Pure MACE   [ Time Frame: Up to Week 14 ]

4.  Primary:   Number of Participants With Hematology Data of Potential Clinical Importance (PCI) at Any Visit Post-Baseline   [ Time Frame: Up to Week 14 ]

5.  Primary:   Number of Participants With Clinical Chemistry Data of PCI at Any Visit Post-Baseline   [ Time Frame: Up to Week 14 ]

6.  Primary:   Number of Participants With Liver Function Test Elevations at Any Time Post-Baseline   [ Time Frame: Up to Week 14 ]

7.  Primary:   Number of Participants With Abnormal Electrocardiogram (ECG) Findings at Any Time Post-Baseline   [ Time Frame: Up to Week 14 ]

8.  Primary:   Number of Participants With Vital Signs of PCI at Any Visit Post-Baseline   [ Time Frame: Up to Week 14 ]

9.  Primary:   Mean High-sensitive C-Reactive Protein (hsCRP) Value at Week 12   [ Time Frame: At Week 12 ]

10.  Primary:   Mean Cardiac Troponin I (cTnI) Area Under Concentration-time Curve (AUC) Over 72 Hours Post-randomization or Until Hospital Discharge (Whichever Comes First)   [ Time Frame: At pre-dose and at 8, 16, 24, 32, 40, 48, 56, 64 and 72 hours ]

11.  Secondary:   Mean hsCRP Over Hospitalization Period and Through Week 14   [ Time Frame: Up to Week 14 ]

12.  Secondary:   Mean Interleukin-6 (IL-6) Value at 24 Hours Post-randomization and at Weeks 2 and 12   [ Time Frame: 24 hours post-randomization and at Weeks 2 and 12 ]

13.  Secondary:   Mean Creatine Kinase (MB Isoenzyme) (CK-MB) AUC Over 72 Hours Post-randomization or Until Hospital Discharge (Whichever Comes First)   [ Time Frame: At pre-dose and at hours 8, 16, 24, 32, 40, 48, 56, 64 and 72 ]

14.  Secondary:   Peak cTnI Over 72 Hours Post-randomization or Until Hospital Discharge (Whichever Comes First)   [ Time Frame: Up to 72 hours ]

15.  Secondary:   Mean Brain Natriuretic Peptide (BNP) at Discharge and Week 12   [ Time Frame: At discharge and Week 12 ]

16.  Secondary:   Mean Infarct Size Prior to Discharge From Hospital (Approximately Day 3) and at Week 12   [ Time Frame: Prior to discharge (visit 1) and at Week 12 ]

17.  Secondary:   Mean Percent Left Ventricular Ejection Fraction (LVEF) at Week 12   [ Time Frame: At Week 12 ]

18.  Secondary:   Mean Left Ventricular End-diastolic Volume (LVEDV) and Left Ventricular End-systolic Volume (LVESV) at Week 12   [ Time Frame: At Week 12 ]

19.  Secondary:   Mean Left Ventricular Mass at Week 12   [ Time Frame: At Week 12 ]

20.  Secondary:   Mean Regional Wall Motion Score Index at Week 12   [ Time Frame: At Week 12 ]

21.  Secondary:   Mean Hyperenhancement Score Index at Week 12   [ Time Frame: At week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00910962     History of Changes
Other Study ID Numbers: 111810
First Submitted: May 28, 2009
First Posted: June 1, 2009
Results First Submitted: August 18, 2017
Results First Posted: October 27, 2017
Last Update Posted: December 7, 2017