Trial · NCT04400487
Actigraphy Improvement With Voxelotor (ActIVe) Study
NCT04400487, Phase 4, Completed, Pfizer; results first posted 2023-11-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Actigraphy Improvement With Voxelotor (ActIVe) Study. Trials, record NCT04400487. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04400487
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Actigraphy Improvement With Voxelotor (ActIVe) Study
- NCT number
- NCT04400487
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 25 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Sickle Cell Disease, Sickle Cell Anemia
- Interventions
- Voxelotor
- First posted
- 2020-05-22
- Last updated
- 2023-11-21
- Results first posted
- 2023-11-21
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Total Daily Physical Activity (Counts Per Minute) to Week 10-12 | Baseline, Week 10-12 | Daily physical activity was measured by actigraphy in participants with sickle cell disease (SCD) and chronic moderate anemia. Actigraphy assessments were performed using wrist-worn tri-axial accelerometry device. Actigraphy is an accepted methodology for tracking activity levels, time spent in moderate and vigorous physical activity, step counts, and energy expenditure. Change from baseline to follow-up visit was calculated as the baseline measurement subtracted from the follow-up measurement for all assessments. In this outcome measure the average of at least 8 valid days during the specified two-week period was considered. A participant's daily wear must be 18 hours or more in a day to be considered a valid day. |
| Primary | Change From Baseline in Total Daily Physical Activity (Counts Per Minute) to Week 22-24 | Baseline, Week 22-24 | Daily physical activity was measured by actigraphy in participants with SCD and chronic moderate anemia. Actigraphy assessments were performed using wrist-worn tri-axial accelerometry device. Actigraphy is an accepted methodology for tracking activity levels, time spent in moderate and vigorous physical activity, step counts, and energy expenditure. Change from baseline to follow-up visit was calculated as the baseline measurement subtracted from the follow-up measurement for all assessments. In this outcome measure the average of at least 8 valid days during the specified two-week period was considered. A participant's daily wear must be 18 hours or more in a day to be considered a valid day. |
| Primary | Change From Baseline in Light Physical Activity to Week 10-12 | Baseline, Week 10-12 | Change in daily physical activity was measured by actigraphy in adolescent and adult participants with SCD and chronic moderate anemia. This outcome measure described the change from baseline in light physical activity. Change from baseline to follow-up visit was calculated as the baseline measurement subtracted from the follow-up measurement for all assessments. In this outcome measure the average of at least 8 valid days during the specified two-week period was considered. A participant's daily wear must be 18 hours or more in a day to be considered a valid day. |
| Primary | Change From Baseline in Light Physical Activity to Week 22-24 | Baseline, Week 22-24 | Change in daily physical activity was measured by actigraphy in adolescent and adult participants with SCD and chronic moderate anemia. This outcome measure described the change from baseline in light physical activity. Change from baseline to follow-up visit was calculated as the baseline measurement subtracted from the follow-up measurement for all assessments. In this outcome measure the average of at least 8 valid days during the specified two-week period was considered. A participant's daily wear must be 18 hours or more in a day to be considered a valid day. |
| Primary | Change From Baseline in Moderate Physical Activity to Week 10-12 | Baseline, Week 10-12 | Change in daily moderate physical activity (minutes per day) was measured by actigraphy in participants with SCD and chronic moderate anemia. Change from baseline to follow-up visit was calculated as the baseline measurement subtracted from the follow-up measurement for all assessments. In this outcome measure the average of at least 8 valid days during the specified two-week period was considered. A participant's daily wear must be 18 hours or more in a day to be considered a valid day. |
| Primary | Change From Baseline in Moderate Physical Activity to Week 22-24 | Baseline, Week 22-24 | Change in daily moderate physical activity (minutes per day) was measured by actigraphy in participants with SCD and chronic moderate anemia. Change from baseline to follow-up visit was calculated as the baseline measurement subtracted from the follow-up measurement for all assessments. In this outcome measure the average of at least 8 valid days during the specified two-week period was considered. A participant's daily wear must be 18 hours or more in a day to be considered a valid day. |
| Primary | Change From Baseline in Vigorous Physical Activity to Week 10-12 | Baseline, Week 10-12 | Change in daily vigorous physical activity (minutes per day) was measured by actigraphy in participants with SCD and chronic moderate anemia. Change from baseline to follow-up visit was calculated as the baseline measurement subtracted from the follow-up measurement for all assessments. In this outcome measure the average of at least 8 valid days during the specified two-week period was considered. A participant's daily wear must be 18 hours or more in a day to be considered a valid day. |
| Primary | Change From Baseline in Vigorous Physical Activity to Week 22-24 | Baseline, Week 22-24 | Change in daily vigorous physical activity (minutes per day) was measured by actigraphy in participants with SCD and chronic moderate anemia. Change from baseline to follow-up visit was calculated as the baseline measurement subtracted from the follow-up measurement for all assessments. In this outcome measure the average of at least 8 valid days during the specified two-week period was considered. A participant's daily wear must be 18 hours or more in a day to be considered a valid day. |
| Primary | Change From Baseline in Total Nocturnal Sleep Time to Week 10-12 | Baseline, Week 10-12 | Total nocturnal sleep time was measured by overnight actigraphy monitoring. Change from baseline to follow-up visit was calculated as the baseline measurement subtracted from the follow-up measurement for all assessments. In this outcome measure the average of at least 8 valid days during the specified two-week period was considered. A participant's daily wear must be 18 hours or more in a day to be considered a valid day. |
| Primary | Change From Baseline in Total Nocturnal Sleep Time to Week 22-24 | Baseline, Week 22-24 | Total nocturnal sleep time was measured by overnight actigraphy monitoring. Change from baseline to follow-up visit was calculated as the baseline measurement subtracted from the follow-up measurement for all assessments. In this outcome measure the average of at least 8 valid days during the specified two-week period was considered. A participant's daily wear must be 18 hours or more in a day to be considered a valid day. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Total Daily Physical Activity (Counts Per Minute) to Week 10-12 | Baseline, Week 10-12 | Participants who received at least 1 dose of voxelotor were included in the safety population. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Counts per minute | MEAN |
| PRIMARY | Change From Baseline in Total Daily Physical Activity (Counts Per Minute) to Week 22-24 | Baseline, Week 22-24 | Participants who received at least 1 dose of voxelotor were included in the safety population. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Counts per minute | MEAN |
| PRIMARY | Change From Baseline in Light Physical Activity to Week 10-12 | Baseline, Week 10-12 | Participants who received at least 1 dose of voxelotor were included in the safety population. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | minutes/day | MEAN |
| PRIMARY | Change From Baseline in Light Physical Activity to Week 22-24 | Baseline, Week 22-24 | Participants who received at least 1 dose of voxelotor were included in the safety population. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | minutes/day | MEAN |
| PRIMARY | Change From Baseline in Moderate Physical Activity to Week 10-12 | Baseline, Week 10-12 | Participants who received at least 1 dose of voxelotor were included in the safety population. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | minutes/day | MEAN |
| PRIMARY | Change From Baseline in Moderate Physical Activity to Week 22-24 | Baseline, Week 22-24 | Participants who received at least 1 dose of voxelotor were included in the safety population. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | minutes/day | MEAN |
| PRIMARY | Change From Baseline in Vigorous Physical Activity to Week 10-12 | Baseline, Week 10-12 | Participants who received at least 1 dose of voxelotor were included in the safety population. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | minutes/day | MEAN |
| PRIMARY | Change From Baseline in Vigorous Physical Activity to Week 22-24 | Baseline, Week 22-24 | Participants who received at least 1 dose of voxelotor were included in the safety population. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Minutes/day | MEAN |
| PRIMARY | Change From Baseline in Total Nocturnal Sleep Time to Week 10-12 | Baseline, Week 10-12 | Participants who received at least 1 dose of voxelotor were included in the safety population. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Minutes/day | MEAN |
| PRIMARY | Change From Baseline in Total Nocturnal Sleep Time to Week 22-24 | Baseline, Week 22-24 | Participants who received at least 1 dose of voxelotor were included in the safety population. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Minutes/day | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Total Daily Physical Activity (Counts Per Minute) to Week 10-12 | Voxelotor | -155.6 | Standard Deviation 458.45 | Counts per minute | |
| Change From Baseline in Total Daily Physical Activity (Counts Per Minute) to Week 22-24 | Voxelotor | -79.4 | Standard Deviation 443.77 | Counts per minute | |
| Change From Baseline in Light Physical Activity to Week 10-12 | Voxelotor | 5.8 | Standard Deviation 62.67 | minutes/day | |
| Change From Baseline in Light Physical Activity to Week 22-24 | Voxelotor | -11.7 | Standard Deviation 115.34 | minutes/day | |
| Change From Baseline in Moderate Physical Activity to Week 10-12 | Voxelotor | -9.0 | Standard Deviation 25.55 | minutes/day | |
| Change From Baseline in Moderate Physical Activity to Week 22-24 | Voxelotor | -5.7 | Standard Deviation 30.01 | minutes/day | |
| Change From Baseline in Vigorous Physical Activity to Week 10-12 | Voxelotor | 0.0 | Standard Deviation 4.94 | minutes/day | |
| Change From Baseline in Vigorous Physical Activity to Week 22-24 | Voxelotor | -1.2 | Standard Deviation 6.52 | Minutes/day | |
| Change From Baseline in Total Nocturnal Sleep Time to Week 10-12 | Voxelotor | 0.3 | Standard Deviation 77.64 | Minutes/day | |
| Change From Baseline in Total Nocturnal Sleep Time to Week 22-24 | Voxelotor | 17.6 | Standard Deviation 141.10 | Minutes/day |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow13
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Screening Period (28 Days) | STARTED | Voxelotor | 25 | |
| Screening Period (28 Days) | COMPLETED | Voxelotor | 25 | |
| Screening Period (28 Days) | NOT COMPLETED | Voxelotor | 0 | |
| Run-in Period (14 Days) | STARTED | Voxelotor | 25 | |
| Run-in Period (14 Days) | COMPLETED | Voxelotor | 25 | |
| Run-in Period (14 Days) | NOT COMPLETED | Voxelotor | 0 | |
| Treatment Period (24 Weeks) | STARTED | Voxelotor | 25 | |
| Treatment Period (24 Weeks) | Treated (With at Least 1 Dose of Study Treatment) | Voxelotor | 25 | |
| Treatment Period (24 Weeks) | COMPLETED | Voxelotor | 23 | |
| Treatment Period (24 Weeks) | NOT COMPLETED | Voxelotor | 2 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 participant flowAdverse events68
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 | Sickle cell anaemia with crisis | Blood and lymphatic system disorders | Voxelotor: SCD Related | 5 | 25 | |
| other | Sickle cell anaemia with crisis | Blood and lymphatic system disorders | Voxelotor: Non-SCD Related | 0 | 25 | |
| other | Diarrhoea | Gastrointestinal disorders | Voxelotor: SCD Related | 0 | 25 | |
| other | Diarrhoea | Gastrointestinal disorders | Voxelotor: Non-SCD Related | 9 | 25 | |
| other | Nausea | Gastrointestinal disorders | Voxelotor: SCD Related | 0 | 25 | |
| other | Nausea | Gastrointestinal disorders | Voxelotor: Non-SCD Related | 6 | 25 | |
| other | Vomiting | Gastrointestinal disorders | Voxelotor: SCD Related | 0 | 25 | |
| other | Vomiting | Gastrointestinal disorders | Voxelotor: Non-SCD Related | 3 | 25 | |
| other | Abdominal pain | Gastrointestinal disorders | Voxelotor: SCD Related | 0 | 25 | |
| other | Abdominal pain | Gastrointestinal disorders | Voxelotor: Non-SCD Related | 2 | 25 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Voxelotor: SCD Related | 0 | 25 |
| Total, all-cause mortality | Voxelotor: Non-SCD Related | 0 | 25 |
| Total, other adverse events | Voxelotor: SCD Related | 5 | 25 |
| Total, other adverse events | Voxelotor: Non-SCD Related | 19 | 25 |
| Total, serious adverse events | Voxelotor: SCD Related | 8 | 25 |
| Total, serious adverse events | Voxelotor: Non-SCD Related | 3 | 25 |
Source ClinicalTrials.gov
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Voxelotor: SCD Related vs Voxelotor: Non-SCD Related: deaths from any cause | Trial comparisons |
| Voxelotor: SCD Related vs Voxelotor: Non-SCD Related: serious adverse events | 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
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/NCT04400487
GET https://conductscience.org/api/trials/v1/NCT04400487/events?page=2