Trial · NCT02135848
3 Month PHI PAD PoM Study
NCT02135848, Phase 2, Completed, GlaxoSmithKline; results first posted 2017-10-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 3 Month PHI PAD PoM Study. Trials, record NCT02135848. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02135848
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 3 Month PHI PAD PoM Study
- NCT number
- NCT02135848
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 46 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Vascular Disease, Peripheral
- Interventions
- GSK1278863, Placebo
- First posted
- 2014-05-12
- Last updated
- 2017-10-20
- Results first posted
- 2017-10-20
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Up to 67 days | AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. |
| Primary | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Up to 39 days | Twelve lead ECGs were recorded with the participant lying supine, having rested in this position for at least 5 minutes before each recording. Full 12 lead ECGs were recorded using an ECG device that automatically calculated the heart rate and measured PR, QRS, RR, QT and QT, QT corrected by Bazett's formula (QTcB) and QT corrected by Fridericia's formula (QTcF) intervals. Number of participants with abnormal (not clinically significant \[NCS\] and clinically significant \[CS\]) ECG findings are presented. |
| Primary | Number of Participants With Vital Signs of Potential Clinical Importance | Up to 39 days | Vital signs included heart rate, systolic and diastolic blood pressure and were performed with the participant in a supine position after the participant had rested for at least 5 minutes. Number of participants with vital signs of potential clinical importance are presented. |
| Primary | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance | Up to 67 days | Clinical chemistry analyte of potential clinical concern included albumin, calcium, creatinine, glucose, magnesium, phosphorus, potassium, sodium and bicarbonate. Number of participants with clinical chemistry abnormalities of potential clinical importance are presented. |
| Primary | Number of Participants With Clinical Hematology Abnormalities of Potential Clinical Importance | Up to 67 days | Hematology parameters included platelet count, red blood cell (RBC) count, white blood cell WBC count (absolute), hemoglobin, hematocrit, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), neutrophils, lymphocytes, monocytes, eosinophils and basophils. Number of participants with clinical hematology abnormalities of potential clinical importance are presented. |
| Secondary | Change From Baseline in Total Number of Contractions to Onset of Claudication | Baseline (Day 1) to Day 39 | At Visit 1 (-21 to -10 days), the participant was introduced to the bilateral heel raise test (BHRT). Test familiarization consisted of the participant performing heel raises to the onset of claudication. The BHRT was conducted with an electrogoniometer instrumented on the index leg. Successive heel raise repetitions were performed once every other second until the participant stopped due to intolerable claudication pain or fatigue, or other criteria for stopping the test were met. The index leg was defined as the leg that met the inclusion symptomatic and hemodynamic criteria (ankle brachial index \[ABI\] ≤ 0.90) with the lowest ABI considered if both legs were affected. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values. |
| Secondary | Change From Baseline in Total Work Performed to Onset of Claudication | Baseline (Day 1) to Day 39 | BHRT is a method to assess muscle performance in participants with claudication. Participants with peripheral artery disease (PAD) and claudication experience reproducible symptoms of leg pain during walking exercise. The symptom of claudication is due to exercise-induced ischemia of muscles in legs, most commonly in calf muscles. At Visit 1 (-21 to -10 days), the participant was introduced to BHRT. Test familiarization consisted of the participant performing heel raises to onset of claudication. BHRT was conducted with an electrogoniometer instrumented on the index leg (leg that met the inclusion symptomatic and hemodynamic criteria \[ABI ≤ 0.90\] with the lowest ABI considered if both legs were affected). Successive heel raise repetitions were performed once every other second until participant stopped due to intolerable claudication pain/fatigue, or other criteria for stopping the test were met. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values. |
| Secondary | Change From Baseline in Total Exercise Time to Onset of Claudication | Baseline (Day 1) to Day 39 | BHRT is a method to assess muscle performance in participants with claudication. Participants with PAD and claudication experience reproducible symptoms of leg pain during walking exercise. The symptom of claudication is due to exercise-induced ischemia of muscles in legs, most commonly in calf muscles. At Visit 1 (-21 to -10 days), the participant was introduced to the BHRT. Test familiarization consisted of the participant performing heel raises to the onset of claudication. The BHRT was conducted with an electrogoniometer instrumented on the index leg (the leg that met the inclusion symptomatic and hemodynamic criteria \[ABI ≤ 0.90\] with the lowest ABI considered if both legs were affected). Successive heel raise repetitions were performed once every other second until the participant stopped due to intolerable claudication pain or fatigue, or other criteria for stopping the test were met. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values. |
| Secondary | Change From Baseline in Total Number of Contractions to Claudication-limited Maximal Muscle Performance | Baseline (Day 1) to Day 39 | BHRT is a method to assess muscle performance in participants with claudication. Participants with PAD and claudication experience reproducible symptoms of leg pain during walking exercise. The symptom of claudication is due to exercise-induced ischemia of muscles in legs, most commonly in calf muscles. At Visit 1 (-21 to -10 days), the participant was introduced to the BHRT. Test familiarization consisted of the participant performing heel raises to the onset of claudication. The BHRT was conducted with an electrogoniometer instrumented on the index leg (the leg that met the inclusion symptomatic and hemodynamic criteria \[ABI ≤ 0.90\] with the lowest ABI considered if both legs were affected). Successive heel raise repetitions were performed once every other second until the participant stopped due to intolerable claudication pain or fatigue, or other criteria for stopping the test were met. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values. |
| Secondary | Change From Baseline in Total Work Performed to Claudication-limited Maximal Muscle Performance | Baseline (Day 1) to Day 39 | BHRT is a method to assess muscle performance in participants with claudication. Participants with PAD and claudication experience reproducible symptoms of leg pain during walking exercise. The symptom of claudication is due to exercise-induced ischemia of muscles in legs, most commonly in calf muscles. At Visit 1 (-21 to -10 days), the participant was introduced to the BHRT. Test familiarization consisted of the participant performing heel raises to the onset of claudication. The BHRT was conducted with an electrogoniometer instrumented on the index leg (the leg that met the inclusion symptomatic and hemodynamic criteria \[ABI ≤ 0.90\] with the lowest ABI considered if both legs were affected). Successive heel raise repetitions were performed once every other second until the participant stopped due to intolerable claudication pain or fatigue, or other criteria for stopping the test were met. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Up to 67 days | Safety population which comprised of all participants who received at least one dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Up to 39 days | Safety Population. Only those participants with data available at the indicated time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Vital Signs of Potential Clinical Importance | Up to 39 days | Safety Population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance | Up to 67 days | Safety Population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinical Hematology Abnormalities of Potential Clinical Importance | Up to 67 days | Safety Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Total Number of Contractions to Onset of Claudication | Baseline (Day 1) to Day 39 | Pharmacodynamic population comprised of all participants who provided pharmacodynamic data, i.e. bilateral heel-raise data or six-minute-walk-test data. Only those participants with data available at the indicated time points were analyzed. | Contractions | MEAN |
| SECONDARY | Change From Baseline in Total Work Performed to Onset of Claudication | Baseline (Day 1) to Day 39 | Pharmacodynamic population. Only those participants available at the specified time points were analyzed. | kilogram-meters | MEAN |
| SECONDARY | Change From Baseline in Total Exercise Time to Onset of Claudication | Baseline (Day 1) to Day 39 | Pharmacodynamic population. Only those participants available at the specified time points were analyzed. | Seconds | MEAN |
| SECONDARY | Change From Baseline in Total Number of Contractions to Claudication-limited Maximal Muscle Performance | Baseline (Day 1) to Day 39 | Pharmacodynamic population. Only those participants available at the specified time points were analyzed. | Contractions | MEAN |
| SECONDARY | Change From Baseline in Total Work Performed to Claudication-limited Maximal Muscle Performance | Baseline (Day 1) to Day 39 | Pharmacodynamic population. Only those participants available at the specified time points were analyzed. | kilogram-meters | MEAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group192
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | GSK1278863 300 mg | AE | 14 | Participants | |
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Placebo Matched With GSK1278863 300 mg | AE | 6 | Participants | |
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | GSK1278863 15 mg | AE | 9 | Participants | |
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Placebo Matched With GSK1278863 15 mg | AE | 3 | Participants | |
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | GSK1278863 300 mg | SAE | 2 | Participants | |
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Placebo Matched With GSK1278863 300 mg | SAE | 0 | Participants | |
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | GSK1278863 15 mg | SAE | 0 | Participants | |
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Placebo Matched With GSK1278863 15 mg | SAE | 1 | Participants | |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings | GSK1278863 300 mg | Acute Day 1, Pre-dose; Abnormal NCS | 14 | Participants | |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Placebo Matched With GSK1278863 300 mg | Acute Day 1, Pre-dose; Abnormal NCS | 16 | Participants |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GSK1278863 | 26 | |
| Overall Study | STARTED | Placebo | 20 | |
| Overall Study | COMPLETED | GSK1278863 | 23 | |
| Overall Study | COMPLETED | Placebo | 19 | |
| Overall Study | NOT COMPLETED | GSK1278863 | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events92
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | GSK1278863 300 mg | 3 | 26 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Matched With GSK1278863 300 mg | 0 | 20 | |
| other | Diarrhoea | Gastrointestinal disorders | GSK1278863 15 mg | 0 | 23 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Matched With GSK1278863 15 mg | 0 | 19 | |
| other | Dyspepsia | Gastrointestinal disorders | GSK1278863 300 mg | 2 | 26 | |
| other | Dyspepsia | Gastrointestinal disorders | Placebo Matched With GSK1278863 300 mg | 0 | 20 | |
| other | Dyspepsia | Gastrointestinal disorders | GSK1278863 15 mg | 0 | 23 | |
| other | Dyspepsia | Gastrointestinal disorders | Placebo Matched With GSK1278863 15 mg | 0 | 19 | |
| other | Flatulence | Gastrointestinal disorders | GSK1278863 300 mg | 0 | 26 | |
| other | Flatulence | Gastrointestinal disorders | Placebo Matched With GSK1278863 300 mg | 1 | 20 |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GSK1278863 300 mg | 0 | 26 |
| Total, all-cause mortality | Placebo Matched With GSK1278863 300 mg | 0 | 20 |
| Total, all-cause mortality | GSK1278863 15 mg | 0 | 23 |
| Total, all-cause mortality | Placebo Matched With GSK1278863 15 mg | 0 | 19 |
| Total, other adverse events | GSK1278863 300 mg | 10 | 26 |
| Total, other adverse events | Placebo Matched With GSK1278863 300 mg | 6 | 20 |
| Total, other adverse events | GSK1278863 15 mg | 3 | 23 |
| Total, other adverse events | Placebo Matched With GSK1278863 15 mg | 3 | 19 |
| Total, serious adverse events | GSK1278863 300 mg | 2 | 26 |
| Total, serious adverse events | Placebo Matched With GSK1278863 300 mg | 0 | 20 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| GSK1278863 vs Placebo: Number of Participants With Clinical Hematology Abnormalities of Potential Clinical Importance |
Source Trial comparisons
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.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02135848
GET https://conductscience.org/api/trials/v1/NCT02135848/registered?page=2