Trial · NCT02603809
Dose-finding Study With ACT-132577 (Aprocitentan) in Participants With Essential Hypertension
NCT02603809, Phase 2, Completed, Idorsia Pharmaceuticals Ltd.; results first posted 2020-04-13
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ConductScience Library. Dose-finding Study With ACT-132577 (Aprocitentan) in Participants With Essential Hypertension. Trials, record NCT02603809. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02603809
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose-finding Study With ACT-132577 (Aprocitentan) in Participants With Essential Hypertension
- NCT number
- NCT02603809
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 1,659 participants, actual
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Conditions
- Essential Hypertension
- Interventions
- Aprocitentan 5 mg, Aprocitentan 10 mg, Aprocitentan 25 mg, Aprocitentan 50 mg, Lisinopril 20 mg, Placebo
- First posted
- 2015-11-13
- Last updated
- 2022-11-23
- Results first posted
- 2020-04-13
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to End of Double-blind Treatment in Sitting Diastolic Blood Pressure at Trough | Baseline (Day 1) and end of double-blind treatment (Day 56) | Participants had their blood pressure measured at the study site using the BpTRU® device. The BpTRU® is an automatic unattended office blood pressure measurement device. Six measurements, at rest, per participant per visit were performed. The mean of the last 5 measurements was used for the analysis. The absolute change in mean trough sitting diastolic blood pressure (SiDBP) measured by from baseline (i.e., at randomization) to week 8 (Day 56). A negative change indicates a decrease in the diastolic blood pressure from the start of treatment. |
| Secondary | Change From Baseline to End of Double-blind Treatment in Sitting Systolic Blood Pressure at Trough | Baseline (Day 1) and end of double-blind treatment (Day 56) | Participants had their blood pressure measured at the study site using the BpTRU® device. The BpTRU® is an automatic unattended office blood pressure measurement device. Six measurements, at rest, per participant per visit were performed. The mean of the last 5 measurements was used for the analysis. The absolute change in mean trough sitting systolic blood pressure (SiSBP) measured by from baseline (i.e., at randomization) to week 8 (Day 56). A negative change indicates a decrease in the systolic blood pressure from the start of treatment. |
| Secondary | Control Rates at the End of the Double-blind Treatment Period Based on Trough Sitting Diastolic and Systolic Blood Pressure | End of double-blind treatment (Day 56) | Participants had their blood pressure measured at the study site using the BpTRU® device. The BpTRU® is an automatic unattended office blood pressure measurement device. Six measurements, at rest, per participant per visit were performed. The mean of the last 5 measurements was used for the analysis. The Canadian Hypertension Education Program (CHEP) issued guidelines proposing cut-offs of 85 mmHg for diastolic blood pressure and 135 mmHg for systolic blood pressure specifically focusing on measurement by automated office blood pressure measurement. The number of participants at the end of the 8-week treatment period that had values below the protocol and CHEP cut-off values are reported. The initial protocol control rates at Week 8 (Day 56) on trough SiDBP are also reported and were defined as a SiDBP of less than 90 mmHg and a SiSBP of less than 140 mmHg. |
| Secondary | Response Rates at End of Double-blind Treatment Period Based on Trough Sitting Diastolic Blood Pressure | Baseline (Day 1) and end of double-blind treatment (Day 56) | Participants had their blood pressure measured at the study site using the BpTRU® device. The BpTRU® is an automatic unattended office blood pressure measurement device. Six measurements, at rest, per participant per visit were performed. The mean of the last 5 measurements was used for the analysis. A participant was a responder if the reduction from baseline in mean trough sitting diastolic blood pressure (SiDBP) was 10 mmHg or greater-than 10 mmHg. |
| Secondary | Response Rates at End of Double-blind Treatment Period Based on Trough Sitting Systolic Blood Pressure | Baseline (Day 1) and end of double-blind treatment (Day 56) | Participants had their blood pressure measured at the study site using the BpTRU® device. The BpTRU® is an automatic unattended office blood pressure measurement device. Six measurements, at rest, per participant per visit were performed. The mean of the last 5 measurements was used for the analysis. A participant was a responder if the reduction from baseline in mean trough sitting systolic blood pressure (SiSBP) was 20 mmHg or greater-than 20 mmHg. |
| Secondary | Change From Baseline to End of Double-blind Treatment in 24-hour Diastolic and Systolic Ambulatory Blood Pressure Monitoring (ABPM) | Baseline (Day -1 to Day 1) and end of double-blind treatment (Day 55 and Day 56) | Diastolic and systolic ambulatory blood pressure monitoring was performed over a 24-hour period with the ABPM device (Mobil-o-Graph) set to record diastolic and systolic blood pressure at a pre-defined time. Over a 24-hour period 3 measurements per hour during the day and 2 per hour during the night were made. The blood pressure measurements were derived from the area under the diastolic and systolic blood pressure curves and divided by the time span and averaged. For ambulatory blood pressure monitoring the baseline was the period from the time of last run-in placebo intake up to the time of the first double-blind treatment intake. |
| Secondary | Ratio of Group Mean at Trough to Group Mean at Peak for Diastolic Blood Pressure Based on Ambulatory Blood Pressure Monitoring (ABPM) | Baseline (Day -1 to Day 1) and end of double-blind treatment (Day 55 and Day 56) | Ratio of group mean at trough to group mean at peak was calculated from the diastolic ambulatory blood pressure monitoring performed over a 24-hour period with the ABPM device. The trough (the smallest blood pressure reduction) and the peak (the highest blood pressure reduction) ratio show the extent of blood pressure lowering throughout the 24-hour dosing interval in the group. The group mean trough (at 20-24 hours) to group mean (at 2-6 hours) peak of diastolic blood pressure were examined to evaluate the extent to which once-daily dosing criteria were met (trough-to-peak values greater than 0.5). The ratio is positive if there was a decrease in diastolic blood pressure at both the trough and peak times at the end of treatment (Day 55 to Day 56) when compared to baseline (Day -1 to Day 1). For ambulatory blood pressure monitoring the baseline was the period from the time of last run-in placebo intake up to the time of the first double-blind treatment intake. |
| Other | Supportive Analysis of Primary Endpoint: Change From Baseline to End of Double-blind Treatment in Sitting Diastolic Blood Pressure at Trough | Baseline (Day -1 to Day 1) and end of double-blind treatment (Day 55 and Day 56) | Participants had their blood pressure measured at the study site using the BpTRU® device. The BpTRU® is an automatic unattended office blood pressure measurement device. Six measurements, at rest, per participant per visit were performed. The mean of the last 5 measurements was used for the analysis. The absolute change in mean trough sitting diastolic blood pressure (SiDBP) measured by from baseline (i.e., at randomization) to week 8 (Day 56). A negative change indicates a decrease in the diastolic blood pressure from the start of treatment. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to End of Double-blind Treatment in Sitting Diastolic Blood Pressure at Trough | Baseline (Day 1) and end of double-blind treatment (Day 56) | Modified Per-protocol set (mPPS). All participants who had a mean trough sitting diastolic blood pressure (SiDBP) at Week-8 of the double-blind treatment period and that did not have any major protocol deviation were analyzed. | mmHg | MEAN |
| SECONDARY | Change From Baseline to End of Double-blind Treatment in Sitting Systolic Blood Pressure at Trough | Baseline (Day 1) and end of double-blind treatment (Day 56) | Modified Per-protocol set (mPPS). All participants who had a mean trough sitting systolic blood pressure (SiSBP) at Week 8 of the double-blind treatment period and that did not have any major protocol deviation were analyzed. | mmHg | MEAN |
| SECONDARY | Control Rates at the End of the Double-blind Treatment Period Based on Trough Sitting Diastolic and Systolic Blood Pressure | End of double-blind treatment (Day 56) | Modified Per Protocol Set (mPPS). All participants who had diastolic and systolic blood pressure measurements at Week 8 of the double-blind treatment period and that did not have any major protocol deviation were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Response Rates at End of Double-blind Treatment Period Based on Trough Sitting Diastolic Blood Pressure | Baseline (Day 1) and end of double-blind treatment (Day 56) | Modified Per Protocol Set (mPPS). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Response Rates at End of Double-blind Treatment Period Based on Trough Sitting Systolic Blood Pressure | Baseline (Day 1) and end of double-blind treatment (Day 56) | Modified Per Protocol Set (mPPS). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline to End of Double-blind Treatment in 24-hour Diastolic and Systolic Ambulatory Blood Pressure Monitoring (ABPM) | Baseline (Day -1 to Day 1) and end of double-blind treatment (Day 55 and Day 56) | All participants in a treatment group with a full set of ABPM (Ambulatory Blood Pressure Monitoring) values over the 24-hour period at baseline and at Week 8. | mmHg | MEAN |
| SECONDARY | Ratio of Group Mean at Trough to Group Mean at Peak for Diastolic Blood Pressure Based on Ambulatory Blood Pressure Monitoring (ABPM) | Baseline (Day -1 to Day 1) and end of double-blind treatment (Day 55 and Day 56) | All participants in a treatment group with a full set of ABPM (Ambulatory Blood Pressure Monitoring) values over the 24-hour period at baseline and at Week 8. | Ratio of mean at trough to mean at peak | NUMBER |
| OTHER_PRE_SPECIFIED | Supportive Analysis of Primary Endpoint: Change From Baseline to End of Double-blind Treatment in Sitting Diastolic Blood Pressure at Trough | Baseline (Day -1 to Day 1) and end of double-blind treatment (Day 55 and Day 56) | The Full Analysis Set (FAS) includes all participants randomized who had a baseline mean trough SiDBP. Participants were evaluated according to the study treatment they have been assigned to. Missing data was analyzed by LOCF (Last Observation Carried Forward). | mmHg | MEAN |
Source ClinicalTrials.gov
Results by group102
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to End of Double-blind Treatment in Sitting Diastolic Blood Pressure at Trough | Placebo | Baseline | 97.5 | Standard Deviation 5.4 | mmHg |
| Change From Baseline to End of Double-blind Treatment in Sitting Diastolic Blood Pressure at Trough | Aprocitentan 5 mg | Baseline | 97.8 | Standard Deviation 5.5 | mmHg |
| Change From Baseline to End of Double-blind Treatment in Sitting Diastolic Blood Pressure at Trough | Aprocitentan 10 mg | Baseline | 97.7 | Standard Deviation 4.3 | mmHg |
| Change From Baseline to End of Double-blind Treatment in Sitting Diastolic Blood Pressure at Trough | Aprocitentan 25 mg | Baseline | 97.8 | Standard Deviation 4.8 | mmHg |
| Change From Baseline to End of Double-blind Treatment in Sitting Diastolic Blood Pressure at Trough | Aprocitentan 50 mg | Baseline | 98.2 | Standard Deviation 5.3 | mmHg |
| Change From Baseline to End of Double-blind Treatment in Sitting Diastolic Blood Pressure at Trough | Lisinopril 20 mg | Baseline | 96.8 | Standard Deviation 4.6 | mmHg |
| Change From Baseline to End of Double-blind Treatment in Sitting Diastolic Blood Pressure at Trough | Placebo | Absolute Change from Baseline to Week 8 | -4.9 | Standard Deviation 11.1 | mmHg |
| Change From Baseline to End of Double-blind Treatment in Sitting Diastolic Blood Pressure at Trough | Aprocitentan 5 mg | Absolute Change from Baseline to Week 8 | -6.3 | Standard Deviation 8.9 | mmHg |
| Change From Baseline to End of Double-blind Treatment in Sitting Diastolic Blood Pressure at Trough | Aprocitentan 10 mg | Absolute Change from Baseline to Week 8 | -9.9 | Standard Deviation 8.7 | mmHg |
| Change From Baseline to End of Double-blind Treatment in Sitting Diastolic Blood Pressure at Trough | Aprocitentan 25 mg | Absolute Change from Baseline to Week 8 | -12.0 | Standard Deviation 8.2 | mmHg |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 82 | |
| Overall Study | STARTED | Aprocitentan 5 mg | 82 | |
| Overall Study | STARTED | Aprocitentan 10 mg | 82 | |
| Overall Study | STARTED | Aprocitentan 25 mg | 82 | |
| Overall Study | STARTED | Aprocitentan 50 mg | 81 | |
| Overall Study | STARTED | Lisinopril 20 mg | 81 | |
| Overall Study | Per-protocol Set | Placebo | 67 | |
| Overall Study | Per-protocol Set | Aprocitentan 5 mg | 68 | |
| Overall Study | Per-protocol Set | Aprocitentan 10 mg | 71 | |
| Overall Study | Per-protocol Set | Aprocitentan 25 mg | 67 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events936
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 | Anaemia | Blood and lymphatic system disorders | Placebo | 0 | 82 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Aprocitentan 5 mg | 0 | 82 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Aprocitentan 10 mg | 0 | 82 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Aprocitentan 25 mg | 2 | 82 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Aprocitentan 50 mg | 1 | 81 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Lisinopril 20 mg | 0 | 81 | 0 |
| other | Eosinophilia | Blood and lymphatic system disorders | Placebo | 0 | 82 | 0 |
| other | Eosinophilia | Blood and lymphatic system disorders | Aprocitentan 5 mg | 0 | 82 | 0 |
| other | Eosinophilia | Blood and lymphatic system disorders | Aprocitentan 10 mg | 0 | 82 | 0 |
| other | Eosinophilia | Blood and lymphatic system disorders | Aprocitentan 25 mg | 1 | 82 | 1 |
1 to 10 of 936Source ClinicalTrials.gov
See all 936 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 82 |
| Total, all-cause mortality | Aprocitentan 5 mg | 0 | 82 |
| Total, all-cause mortality | Aprocitentan 10 mg | 0 | 82 |
| Total, all-cause mortality | Aprocitentan 25 mg | 0 | 82 |
| Total, all-cause mortality | Aprocitentan 50 mg | 0 | 81 |
| Total, all-cause mortality | Lisinopril 20 mg | 0 | 81 |
| Total, other adverse events | Placebo | 30 | 82 |
| Total, other adverse events | Aprocitentan 5 mg | 18 | 82 |
| Total, other adverse events | Aprocitentan 10 mg | 24 | 82 |
| Total, other adverse events | Aprocitentan 25 mg | 32 | 82 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32063059 | DERIVED |
Source PubMed
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.
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/NCT02603809
GET https://conductscience.org/api/trials/v1/NCT02603809/results?page=2