Trial · NCT03541174
A Research Study to Show the Effect of Aprocitentan in the Treatment of Difficult to Control (Resistant) High Blood Pressure (Hypertension) and Find Out More About Its Safety
NCT03541174, Phase 3, Completed, Idorsia Pharmaceuticals Ltd.; results first posted 2023-03-21
3 sourcestrials-2026-11-12-0.4.0
Download JSON
Cite this record
ConductScience Library. A Research Study to Show the Effect of Aprocitentan in the Treatment of Difficult to Control (Resistant) High Blood Pressure (Hypertension) and Find Out More About Its Safety. Trials, record NCT03541174. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03541174
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Research Study to Show the Effect of Aprocitentan in the Treatment of Difficult to Control (Resistant) High Blood Pressure (Hypertension) and Find Out More About Its Safety
- NCT number
- NCT03541174
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 730 participants, actual
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Conditions
- Resistant Hypertension
- Interventions
- Aprocitentan 12.5 mg, Aprocitentan 25 mg, Placebo
- First posted
- 2018-05-30
- Last updated
- 2023-03-21
- Other registries' IDs
- eudract:2017-004393-33
- Results first posted
- 2023-03-21
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 4 of Double-blind Treatment in Mean Trough Sitting Systolic Blood Pressure (SiSBP) Measured by Automated Office Blood Pressure Measurement | Pre-dose Day 1 (Part 1 double-blind randomized baseline) up to Week 4 (End of double-blind randomized part 1) | Changes from baseline to Week 4 in mean trough SiSBP were analyzed using a mixed model. Participants had their blood pressure (BP) measured at the study site using the automated oscillometric sphygmomanometer (Microlife WatchBP® Office) which was provided to each site. BP was to be measured at trough (before taking the study treatment and SBAT). The BP assessment, participant preparation (e.g., arm selection, arm position, cuff size) was standardized and followed the American Heart Association guidelines / Canadian Education Program on Hypertension. The participant was resting undisturbed, alone (unattended) in a quiet place for 5 minutes at each visit. BP was measured at each visit with the same device, which recorded five sitting blood pressure readings (one per minute, the first value was excluded from the average). A negative change indicates a decrease in SiSBP from baseline. |
| Secondary | Change From Double-blind Withdrawal Baseline (Week 36) to Week 40 in Mean Trough Sitting Systolic Blood Pressure (SiSBP) Measured by Unattended Automated Office Blood Pressure Measurement | Pre-dose Week 36 (Part 3 double-blind-withdrawal baseline) up to Week 40 | Changes from double-blind withdrawal baseline (Week 36) to Week 40 in mean trough SiSBP were analyzed using a mixed model. Participants had their blood pressure (BP) measured at the study site using the automated oscillometric sphygmomanometer (Microlife WatchBP® Office) which was provided to each site. BP was to be measured at trough (before taking the study treatment and SBAT). The BP assessment, participant preparation (e.g., arm selection, arm position, cuff size) was standardized and followed the American Heart Association guidelines / Canadian Education Program on Hypertension. The participant was resting undisturbed, alone (unattended) in a quiet place for 5 minutes at each visit. BP was measured at each visit with the same device, which recorded five sitting blood pressure readings (one per minute, the first value was excluded from the average). A negative change indicates a decrease in SiSBP from baseline. |
| Secondary | Change From Baseline to Week 4 of Double-blind Treatment in Mean Trough Sitting Diastolic Blood Pressure (SiDBP) Measured by Unattended Automated Office Blood Pressure Measurement | Pre-dose Day 1 (Part 1 double-blind randomized baseline) up to Week 4 (End of double-blind randomized part 1) | Changes from baseline to Week 4 in mean trough SiDBP were analyzed using a mixed model. Participants had their blood pressure (BP) measured at the study site using the automated oscillometric sphygmomanometer (Microlife WatchBP® Office) which was provided to each site. BP was to be measured at trough (before taking the study treatment and SBAT). The BP assessment, participant preparation (e.g., arm selection, arm position, cuff size) was standardized and followed the American Heart Association guidelines / Canadian Education Program on Hypertension. BP was measured at each visit with the same device, which recorded five sitting blood pressure readings (one per minute, the first value was excluded from the average). The participant was resting undisturbed, alone (unattended) in a quiet place for 5 minutes at each visit. A negative change indicates a decrease in SiDBP from baseline. |
| Secondary | Changes From Baseline to Week 4 of Double-blind Treatment in 24-hour Mean Systolic (SBP) and Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring | Pre-dose Day 1 (Part 1 double-blind randomized baseline) and Week 4 (End of double-blind randomized part 1) | ABPM devices were provided to each site by the central blood pressure laboratory. On the first day after all visit assessments were performed, the ABPM device (Mobil-O-Graph NG) was fitted to the participant. The following day (i.e., second day), the participant came back to site to have the ABPM device removed. ABPM data collected over the 24-hours was electronically transferred to the central BP laboratory. Systolic blood pressure and diastolic blood pressure were measured at predetermined times every 20 minutes from 06:00 to 21:59, and every 30 minutes from 22:00 to 05:59. For each participant and at each visit (baseline and Week 4) the 24-hour mean SBP (or DBP) was calculated from the area under the SBP (or DBP) time curve and divided by the time span. A negative change indicates a decrease in 24-hour mean systolic / diastolic blood pressure from baseline. |
| Secondary | Change From Double-blind Withdrawal Baseline (Week 36) to Week 40 of Double-blind-withdrawal (DB-WD) Treatment in Trough Sitting Diastolic Blood Pressure (SiDBP) Measured by Unattended Automated Office Blood Pressure | Pre-dose Week 36 (Part 3 double-blind-withdrawal baseline) up to Week 40 | Changes from double-blind withdrawal (Week 36) to Week 40 in mean trough SiDBP were analyzed using a mixed model. Participants had their blood pressure (BP) measured at the study site using the automated oscillometric sphygmomanometer (Microlife WatchBP® Office) which was provided to each site. BP was to be measured at trough (before taking the study treatment and SBAT). The BP assessment, participant preparation (e.g., arm selection, arm position, cuff size) was standardized and followed the American Heart Association guidelines / Canadian Education Program on Hypertension. The participant was resting undisturbed, alone (unattended) in a quiet place for 5 minutes at each visit. BP was measured at each visit with the same device, which recorded five sitting blood pressure readings (one per minute, the first value was excluded from the average). A negative change indicates a decrease in SiDBP from baseline. |
| Secondary | Changes From Double-blind Withdrawal Baseline (Week 36) to Week 40 of Double-blind-withdrawal (DB-WD) Treatment in 24-hour Mean Systolic (SBP) and Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring | From Week 36 (Part 3 double-blind-withdrawal baseline) and Week 40 | ABPM devices were provided to each site by the central blood pressure laboratory. On the first day after all visit assessments were performed, the ABPM device (Mobil-O-Graph NG) was fitted to the participant. The following day (i.e., second day), the participant came back to site to have the ABPM device removed. ABPM data collected over the 24-hours was electronically transferred to the central BP laboratory. Systolic blood pressure and diastolic blood pressure were measured at predetermined times every 20 minutes from 06:00 to 21:59, and every 30 minutes from 22:00 to 05:59. For each participant and at each visit (the double-blind withdrawal baseline \[Week 36\] and the week 40) the 24-hour mean SBP (or DBP) was calculated from the area under the SBP (or DBP) time curve. A negative change indicates a decrease in 24-hour mean systolic / diastolic blood pressure from baseline. |
Source ClinicalTrials.gov
Outcomes6
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 Week 4 of Double-blind Treatment in Mean Trough Sitting Systolic Blood Pressure (SiSBP) Measured by Automated Office Blood Pressure Measurement | Pre-dose Day 1 (Part 1 double-blind randomized baseline) up to Week 4 (End of double-blind randomized part 1) | The Full Analysis Set (FAS) includes all participants who were randomized and had a baseline sitting systolic blood pressure, measured by automated office blood pressure measurement. Baseline was defined as the last measurement before randomization. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Double-blind Withdrawal Baseline (Week 36) to Week 40 in Mean Trough Sitting Systolic Blood Pressure (SiSBP) Measured by Unattended Automated Office Blood Pressure Measurement | Pre-dose Week 36 (Part 3 double-blind-withdrawal baseline) up to Week 40 | The modified FAS (mFAS) includes all participants from the FAS who were re-randomized in the double-blind-withdrawal part (DB-WD) of the study and who have a DB-WD baseline sitting systolic blood pressure, measured by automatic office blood pressure measurement device at trough. Baseline was defined as the last measurement before re-randomization. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 4 of Double-blind Treatment in Mean Trough Sitting Diastolic Blood Pressure (SiDBP) Measured by Unattended Automated Office Blood Pressure Measurement | Pre-dose Day 1 (Part 1 double-blind randomized baseline) up to Week 4 (End of double-blind randomized part 1) | The Full Analysis Set (FAS) includes all participants who were randomized and had a baseline sitting systolic blood pressure, measured by automated office blood pressure measurement. Baseline was defined as the last measurement before randomization. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Changes From Baseline to Week 4 of Double-blind Treatment in 24-hour Mean Systolic (SBP) and Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring | Pre-dose Day 1 (Part 1 double-blind randomized baseline) and Week 4 (End of double-blind randomized part 1) | The ambulatory blood pressure monitoring full analysis set (aFAS) includes all participants from the FAS who have a baseline 24-hour mean systolic and diastolic blood pressure measured by ambulatory blood pressure monitoring with a total duration of at least 21 hours and at least 70% valid readings. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Double-blind Withdrawal Baseline (Week 36) to Week 40 of Double-blind-withdrawal (DB-WD) Treatment in Trough Sitting Diastolic Blood Pressure (SiDBP) Measured by Unattended Automated Office Blood Pressure | Pre-dose Week 36 (Part 3 double-blind-withdrawal baseline) up to Week 40 | The modified FAS (mFAS) includes all participants in the FAS who were re-randomized in the double-blind-withdraw part of the study and who had a week 36 sitting systolic blood pressure, measured by automated office blood pressure measurement. Baseline was defined as the last measurement before re-randomization into part 3 of the double-blind withdrawal part of the study. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Changes From Double-blind Withdrawal Baseline (Week 36) to Week 40 of Double-blind-withdrawal (DB-WD) Treatment in 24-hour Mean Systolic (SBP) and Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring | From Week 36 (Part 3 double-blind-withdrawal baseline) and Week 40 | The modified ambulatory blood pressure monitoring full analysis set (maFAS) includes all participants from the modified Full Analysis Set (mFAS) who had a double-blind withdrawal (DB-WD) baseline 24-hour mean systolic and diastolic blood pressure, measured by ambulatory blood Pressure monitoring (ABPM) with a total duration of at least 21 hours and at least 70% valid readings. | mmHg | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group20
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 Week 4 of Double-blind Treatment in Mean Trough Sitting Systolic Blood Pressure (SiSBP) Measured by Automated Office Blood Pressure Measurement | Aprocitentan 12.5 mg in Part 1 (Double-blind) | -15.26 | 97.5% Confidence Interval -17.36 to -13.17 | mmHg | |
| Change From Baseline to Week 4 of Double-blind Treatment in Mean Trough Sitting Systolic Blood Pressure (SiSBP) Measured by Automated Office Blood Pressure Measurement | Aprocitentan 25 mg in Part 1 (Double-blind) | -15.20 | 97.5% Confidence Interval -17.27 to -13.13 | mmHg | |
| Change From Baseline to Week 4 of Double-blind Treatment in Mean Trough Sitting Systolic Blood Pressure (SiSBP) Measured by Automated Office Blood Pressure Measurement | Placebo in Part 1 (Double-blind) | -11.47 | 97.5% Confidence Interval -13.57 to -9.38 | mmHg | |
| Change From Double-blind Withdrawal Baseline (Week 36) to Week 40 in Mean Trough Sitting Systolic Blood Pressure (SiSBP) Measured by Unattended Automated Office Blood Pressure Measurement | Aprocitentan 25 mg in Part 3 (Double-blind Withdrawal) | -1.47 | 95% Confidence Interval -2.97 to 0.04 | mmHg | |
| Change From Double-blind Withdrawal Baseline (Week 36) to Week 40 in Mean Trough Sitting Systolic Blood Pressure (SiSBP) Measured by Unattended Automated Office Blood Pressure Measurement | Placebo in Part 3 (Double-blind Withdrawal) | 4.36 | 95% Confidence Interval 2.87 to 5.85 | mmHg | |
| Change From Baseline to Week 4 of Double-blind Treatment in Mean Trough Sitting Diastolic Blood Pressure (SiDBP) Measured by Unattended Automated Office Blood Pressure Measurement | Aprocitentan 12.5 mg in Part 1 (Double-blind) | -10.43 | 95% Confidence Interval -11.58 to -9.27 | mmHg | |
| Change From Baseline to Week 4 of Double-blind Treatment in Mean Trough Sitting Diastolic Blood Pressure (SiDBP) Measured by Unattended Automated Office Blood Pressure Measurement | Aprocitentan 25 mg in Part 1 (Double-blind) | -10.95 | 95% Confidence Interval -12.09 to -9.82 | mmHg | |
| Change From Baseline to Week 4 of Double-blind Treatment in Mean Trough Sitting Diastolic Blood Pressure (SiDBP) Measured by Unattended Automated Office Blood Pressure Measurement | Placebo in Part 1 (Double-blind) | -6.48 | 95% Confidence Interval -7.63 to -5.33 | mmHg | |
| Changes From Baseline to Week 4 of Double-blind Treatment in 24-hour Mean Systolic (SBP) and Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring | Aprocitentan 12.5 mg in Part 1 (Double-blind) | 24-hour mean systolic blood pressure | -6.73 | 95% Confidence Interval -8.20 to -5.26 | mmHg |
| Changes From Baseline to Week 4 of Double-blind Treatment in 24-hour Mean Systolic (SBP) and Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring | Aprocitentan 25 mg in Part 1 (Double-blind) | 24-hour mean systolic blood pressure | -8.44 | 95% Confidence Interval -9.88 to -7.00 | mmHg |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow66
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 Double-Blind | STARTED | Aprocitentan 12.5 mg in Part 1 (Double-blind) | 243 | |
| Part 1 Double-Blind | STARTED | Aprocitentan 25 mg in Part 1 (Double-blind) | 243 | |
| Part 1 Double-Blind | STARTED | Placebo in Part 1 (Double-blind) | 244 | |
| Part 1 Double-Blind | STARTED | Aprocitentan 25 mg in Part 2 (Single-blind) | 0 | |
| Part 1 Double-Blind | STARTED | Aprocitentan 25 mg in Part 3 (Double-blind Withdrawal) | 0 | |
| Part 1 Double-Blind | STARTED | Placebo in Part 3 (Double-blind Withdrawal) | 0 | |
| Part 1 Double-Blind | Safety Set | Aprocitentan 12.5 mg in Part 1 (Double-blind) | 243 | |
| Part 1 Double-Blind | Safety Set | Aprocitentan 25 mg in Part 1 (Double-blind) | 245 | |
| Part 1 Double-Blind | Safety Set | Placebo in Part 1 (Double-blind) | 242 | |
| Part 1 Double-Blind | Safety Set | Aprocitentan 25 mg in Part 2 (Single-blind) | 0 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 participant flowAdverse events630
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 | Oedema peripheral | General disorders | Aprocitentan 12.5 mg in Part 1 (Double-blind) | 16 | 243 | 16 |
| other | Oedema peripheral | General disorders | Aprocitentan 25 mg in Part 1 (Double-blind) | 34 | 245 | 34 |
| other | Oedema peripheral | General disorders | Placebo in Part 1 (Double-blind) | 5 | 242 | 5 |
| other | Oedema peripheral | General disorders | Aprocitentan 25 mg in Part 2 (Single-blind) | 95 | 704 | 102 |
| other | Oedema peripheral | General disorders | Aprocitentan 25 mg in Part 3 (Double-blind Withdrawal) | 6 | 310 | 7 |
| other | Oedema peripheral | General disorders | Placebo in Part 3 (Double-blind Withdrawal) | 4 | 303 | 4 |
| serious | Anaemia | Blood and lymphatic system disorders | Aprocitentan 12.5 mg in Part 1 (Double-blind) | 0 | 243 | 0 |
| serious | Anaemia | Blood and lymphatic system disorders | Aprocitentan 25 mg in Part 1 (Double-blind) | 0 | 245 | 0 |
| serious | Anaemia | Blood and lymphatic system disorders | Placebo in Part 1 (Double-blind) | 0 | 242 | 0 |
| serious | Anaemia | Blood and lymphatic system disorders | Aprocitentan 25 mg in Part 2 (Single-blind) | 1 | 704 | 1 |
1 to 10 of 630Source ClinicalTrials.gov
See all 630 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aprocitentan 12.5 mg in Part 1 (Double-blind) | 1 | 243 |
| Total, all-cause mortality | Aprocitentan 25 mg in Part 1 (Double-blind) | 0 | 245 |
| Total, all-cause mortality | Placebo in Part 1 (Double-blind) | 0 | 242 |
| Total, all-cause mortality | Aprocitentan 25 mg in Part 2 (Single-blind) | 9 | 704 |
| Total, all-cause mortality | Aprocitentan 25 mg in Part 3 (Double-blind Withdrawal) | 1 | 310 |
| Total, all-cause mortality | Placebo in Part 3 (Double-blind Withdrawal) | 0 | 303 |
| Total, other adverse events | Aprocitentan 12.5 mg in Part 1 (Double-blind) | 16 | 243 |
| Total, other adverse events | Aprocitentan 25 mg in Part 1 (Double-blind) | 34 | 245 |
| Total, other adverse events | Placebo in Part 1 (Double-blind) | 5 | 242 |
| Total, other adverse events | Aprocitentan 25 mg in Part 2 (Single-blind) | 95 | 704 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers8
The papers the trial lists on ClinicalTrials.gov.
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/NCT03541174
GET https://conductscience.org/api/trials/v1/NCT03541174/flow?page=2