Trial · NCT01506895
A Phase 2 Clinical Study to Investigate Effects of Darapladib in Subjects With Diabetic Macular Edema
NCT01506895, Phase 2, Completed, GlaxoSmithKline
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Phase 2 Clinical Study to Investigate Effects of Darapladib in Subjects With Diabetic Macular Edema. Trials, record NCT01506895. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01506895
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2 Clinical Study to Investigate Effects of Darapladib in Subjects With Diabetic Macular Edema
- NCT number
- NCT01506895
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 54 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Retinopathy, Diabetic
- Interventions
- darapladib, placebo
- First posted
- 2012-01-10
- Last updated
- 2016-11-21
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline in Visual Acuity as measured by ETDRS BCVA | 3 months | Mean change from baseline in ETDRS Best Corrected Visual Acuity (BCVA) after 3 months of treatment |
| Primary | Change from baseline in Spectral Domain Optical Coherance Tomography | 3 months | Mean change from baseline in SD-OCT after 3 months of treatment |
| Secondary | Changes in Retinal Anatomy | 3 months | Changes in retinal anatomy as assessed by fluorescein angiography and fundus photography and SD-OCT in the study eye |
| Secondary | Safety and Tolerability as assessed by change from baseline in outcome measures | 3 months | Safety and tolerability as assesed by: change from baseline in blood pressure and heart rate; assessed by change from baseline in complete ophthalmic exam and visual acuity; assessed by change from baseline in clinical laboratory tests; assessed by change from baseline in the collection of adverse events |
| Secondary | Changes in Pharmacodynamic LP-PLA2 enzyme inhibition | 3 months | Changes over 3 months in the study of LP-PLA2 Enzyme inhibition as data permit |
| Secondary | Peak plasma concentration (Cmax) of study drug | 3 months | Plasma Pharmacokinetic parameters of darapladib as data permit |
| Secondary | Plasma concentration versus time curve (AUC) of study drug | 3 months | Plasma Pharmacokinetic parameters of darapladib as data permit |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01506895
GET https://conductscience.org/api/trials/v1/NCT01506895/registered