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Dose-finding Study With ACT-132577 (Aprocitentan) in Participants With Essential Hypertension

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Aprocitentan 5 mg
Aprocitentan 10 mg
Aprocitentan 25 mg
Aprocitentan 50 mg
Lisinopril 20 mg
Placebo
Sponsored by
Idorsia Pharmaceuticals Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed informed consent prior to any study-mandated procedure
  • No contra-indication to stop (according to label) anti-hypertensive treatment(s) at screening

  • Mild-to-moderate essential hypertension with or without ongoing anti-hypertensive treatment(s):

    -- Mean (of 5 measurements) sitting diastolic blood pressure (SiDBP) ≥ 90 to < 110 mmHg measured by office blood pressure measurements (OBPM).

  • Women of childbearing potential must have a negative pregnancy test and use of reliable methods of contraception

Exclusion Criteria:

  • Severe hypertension (grade 3): mean sitting systolic/diastolic BP (SiSBP/SiDBP; measured by OBPM) ≥ 180/110 mmHg, respectively.
  • Secondary hypertension
  • Known hypertensive retinopathy greater than Keith-Wagener Grade 2
  • Myocardial infarction, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft within 12 months prior to randomization
  • Unstable angina within 6 months prior to randomization
  • Heart failure New York Heart Association class III and IV
  • Valvular defects (such as severe aortic or mitral valve disease) and/or hemodynamically relevant rhythm disturbances
  • Clinical evidence of cerebrovascular insufficiency or a cerebrovascular accident within 6 months prior to randomization.
  • Subjects working night shifts
  • Body mass index < 20 kg/m2 or > 40 kg/m2
  • Treatment with any medication which may affect BP (e.g., treatment of psychiatric diseases, ophthalmic preparations)
  • Treatment with strong cytochrome P450 3A4 (CYP3A4) isoenzyme inhibitors or inducers
  • Treatment with guanethidine and/or mineralocorticoid receptor antagonists within 1 month prior to Screening (Visit 1)
  • Treatment with another investigational treatment within 1 month prior to Screening (Visit 1)
  • Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol

Sites / Locations

  • Appalachian Cardiovascular Associates
  • Radiant Research Inc
  • Warner Family Practice / Radiant Research Inc
  • Phoenix Medical Research Institute LLC
  • Advanced Arizona Clinical Research
  • Noble Clinical Research LLC
  • Desert Sun Clinical Research LLc
  • Advanced Research Center Inc
  • Med Center
  • John Muir Physician Network Clinical Research Center
  • Clinical Trials Research
  • Long Beach Center for Clinical Research
  • Entertainment Medical Group Inc
  • Artemis institute for Clinical Research
  • Memorial Research Medical Clinic / Orange County Research Center
  • Empire Clinical Research
  • Clinical Research Consulting LLC
  • Chase Medical Research LLC
  • Alfieri Cardiology
  • ACRC - Cardiology
  • Innovative Research of West Florida INC
  • Avail Clinical Research LLC
  • Alan Graff, MD, PA
  • Gulfcoast Clinical Research Center
  • AGA Clinical Trials
  • Canvas Clinical Research, LLC
  • LCC Medical Research Institute
  • Allied Biomedical Research Institute, INC
  • Southeast Regional Research Group
  • Community Clin Res CTR
  • Midwest Institute for Clinical Research
  • Heartland Research Associated LLC
  • Heartland Research Associates LLC
  • Heartland Research Associates LLC
  • Avant Research Associates, LLC
  • Best Clinical Trials LLC
  • New Orleans Center for Clinical Research - Nola
  • Clinsite LLC
  • Primecare Research Associates, LLC
  • Clinical Research Advantage, Inc. / Diagnostic Center Of Medicine - Durango
  • Premier Research
  • Rochester Clinical Research Inc.
  • Metrolina Internal Medicine/Internal Medicine Research
  • Pharmquest LLC
  • Peters Medical Research
  • Wake Research Associates
  • Lillestol Research LLC
  • Sterling Research Group Ltd.
  • Aventiv Research Inc.
  • Dayton Clinical Research
  • Aventiv Research Inc.
  • Oklahoma City Clinic - Edmond / Radiant Research Inc
  • Clinical Research Advantage, Inc. / Oklahoma City Clinic - Midwest City
  • Willamette Valley Clinical Studies
  • Detweiler Family Medicine and Associates PC
  • Suburban Research Center
  • Degarmo Institute of Medical Research
  • Volunteer Research Group
  • Tekton Research Inc
  • Texas Diabetes & Endocrinology
  • Trinity Hypertension & Metabolic Research Institute
  • Family Medicine Associates of Texas - ACRC Trials
  • Coastal Bend Clinical Research
  • TR - Global Medical Research
  • Ventavia Research Group, LLC
  • Clinical Investigations of Texas
  • Avant Research Associates LLC
  • Texas Diabetes & Endocrinology
  • Radiant Research Inc
  • Bandera Family Health Care
  • Wasatch Clinical Research LLC
  • Health Research of Hampton Roads
  • National Clinical Research Inc
  • Northwest Clinical Research Center
  • Manna Research - Vancouver
  • Canadian Phase Onwards Inc
  • Manna Research - Toronto
  • Manna Research - Levis
  • Diex Recherche Montreal Inc
  • Diex Recherche Montreal Inc
  • Manna Research - Pointe Claire
  • Diex Reserach Sherbrooke Inc
  • Cardiology Department Barzilai
  • Soroka University Hospital - Hypertension Unit
  • The Hyper Unit, Edith Wolfson Medical Center
  • Hypertension Treatment Center, Internal Dep, Hadassah
  • Hypertension And Nephrology Department, Meir Medical Center
  • Clinical Research Unit Kaplan Medical Center
  • Internal Med Department A, Ziv Medical Center
  • Advanced Medical Concepts, PSC
  • Research & Cardiovascular Corp.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Placebo

Aprocitentan 5 mg

Aprocitentan 10 mg

Aprocitentan 25 mg

Aprocitentan 50 mg

Lisinopril 20 mg

Arm Description

After a 4 to 6-week single-blind placebo run-in period, participants will be randomized to received placebo orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.

After a 4 to 6-week single-blind placebo run-in period, participants will be randomized to received aprocitentan orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.

After a 4 to 6-week single-blind placebo run-in period, participants will be randomized to received aprocitentan 10 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.

After a 4 to 6-week single-blind placebo run-in period, participants will be randomized to received aprocitentan 25 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.

After a 4 to 6-week single-blind placebo run-in period, participants will be randomized to received aprocitentan 50 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.

After a 4 to 6-week single-blind placebo run-in period, participants will be randomized to received lisinopril 20 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.

Outcomes

Primary Outcome Measures

Change From Baseline to End of Double-blind Treatment in Sitting Diastolic Blood Pressure at Trough
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 Outcome Measures

Change From Baseline to End of Double-blind Treatment in Sitting Systolic Blood Pressure at Trough
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.
Control Rates at the End of the Double-blind Treatment Period Based on Trough Sitting Diastolic and Systolic Blood Pressure
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.
Response Rates at End of Double-blind Treatment Period Based on Trough Sitting Diastolic Blood Pressure
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.
Response Rates at End of Double-blind Treatment Period Based on Trough Sitting Systolic Blood Pressure
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.
Change From Baseline to End of Double-blind Treatment in 24-hour Diastolic and Systolic Ambulatory Blood Pressure Monitoring (ABPM)
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.
Ratio of Group Mean at Trough to Group Mean at Peak for Diastolic Blood Pressure Based on Ambulatory Blood Pressure Monitoring (ABPM)
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.

Full Information

First Posted
November 9, 2015
Last Updated
November 22, 2022
Sponsor
Idorsia Pharmaceuticals Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02603809
Brief Title
Dose-finding Study With ACT-132577 (Aprocitentan) in Participants With Essential Hypertension
Official Title
A Multi-center, Double-blind, Double-dummy, Randomized, Placebo- and Active-reference, Parallel Group, Phase 2, Dose-finding Study With ACT-132577 in Subjects With Essential Hypertension (Grade 1 and 2).
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 14, 2015 (Actual)
Primary Completion Date
February 28, 2017 (Actual)
Study Completion Date
April 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Idorsia Pharmaceuticals Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main objective will be to evaluate the dose-response of ACT-132577 (aprocitentan) on diastolic blood pressure (DBP) in participants with grade 1 or 2 essential hypertension. Secondary objectives will be to evaluate the dose-response of ACT-132577 on: systolic blood pressure (SBP); control and response rate of blood pressure; 24-hour ambulatory blood pressure monitoring (ABPM) and to evaluate the safety and tolerability of a once daily oral regimen of 4 doses of ACT-132577.
Detailed Description
Participation in the study is planned to last up to 18 weeks. A single-blind placebo run-in period of 4 to 6 weeks after which participants will be randomized into a double-blind treatment period of 8 weeks and a washout and follow-up period ending with an end-of-study visit approximately 12 weeks after randomization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1659 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
After a 4 to 6-week single-blind placebo run-in period, participants will be randomized to received placebo orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
Arm Title
Aprocitentan 5 mg
Arm Type
Experimental
Arm Description
After a 4 to 6-week single-blind placebo run-in period, participants will be randomized to received aprocitentan orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
Arm Title
Aprocitentan 10 mg
Arm Type
Experimental
Arm Description
After a 4 to 6-week single-blind placebo run-in period, participants will be randomized to received aprocitentan 10 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
Arm Title
Aprocitentan 25 mg
Arm Type
Experimental
Arm Description
After a 4 to 6-week single-blind placebo run-in period, participants will be randomized to received aprocitentan 25 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
Arm Title
Aprocitentan 50 mg
Arm Type
Experimental
Arm Description
After a 4 to 6-week single-blind placebo run-in period, participants will be randomized to received aprocitentan 50 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
Arm Title
Lisinopril 20 mg
Arm Type
Active Comparator
Arm Description
After a 4 to 6-week single-blind placebo run-in period, participants will be randomized to received lisinopril 20 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
Intervention Type
Drug
Intervention Name(s)
Aprocitentan 5 mg
Other Intervention Name(s)
ACT-132577
Intervention Description
One capsule of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.
Intervention Type
Drug
Intervention Name(s)
Aprocitentan 10 mg
Other Intervention Name(s)
ACT-132577
Intervention Description
Two capsules of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Aprocitentan 25 mg
Other Intervention Name(s)
ACT-132577
Intervention Description
One capsule of 25 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.
Intervention Type
Drug
Intervention Name(s)
Aprocitentan 50 mg
Other Intervention Name(s)
ACT-132577
Intervention Description
One capsule of 50 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.
Intervention Type
Drug
Intervention Name(s)
Lisinopril 20 mg
Intervention Description
One capsule of 20 mg lisinopril, orally, once daily in the morning for 8 weeks, along with placebo capsule matching aprocitentan
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One capsule each of placebo matching aprocitentan and placebo matching lisinopril orally, once daily in the morning for 8 weeks.
Primary Outcome Measure Information:
Title
Change From Baseline to End of Double-blind Treatment in Sitting Diastolic Blood Pressure at Trough
Description
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.
Time Frame
Baseline (Day 1) and end of double-blind treatment (Day 56)
Secondary Outcome Measure Information:
Title
Change From Baseline to End of Double-blind Treatment in Sitting Systolic Blood Pressure at Trough
Description
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.
Time Frame
Baseline (Day 1) and end of double-blind treatment (Day 56)
Title
Control Rates at the End of the Double-blind Treatment Period Based on Trough Sitting Diastolic and Systolic Blood Pressure
Description
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.
Time Frame
End of double-blind treatment (Day 56)
Title
Response Rates at End of Double-blind Treatment Period Based on Trough Sitting Diastolic Blood Pressure
Description
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.
Time Frame
Baseline (Day 1) and end of double-blind treatment (Day 56)
Title
Response Rates at End of Double-blind Treatment Period Based on Trough Sitting Systolic Blood Pressure
Description
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.
Time Frame
Baseline (Day 1) and end of double-blind treatment (Day 56)
Title
Change From Baseline to End of Double-blind Treatment in 24-hour Diastolic and Systolic Ambulatory Blood Pressure Monitoring (ABPM)
Description
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.
Time Frame
Baseline (Day -1 to Day 1) and end of double-blind treatment (Day 55 and Day 56)
Title
Ratio of Group Mean at Trough to Group Mean at Peak for Diastolic Blood Pressure Based on Ambulatory Blood Pressure Monitoring (ABPM)
Description
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.
Time Frame
Baseline (Day -1 to Day 1) and end of double-blind treatment (Day 55 and Day 56)
Other Pre-specified Outcome Measures:
Title
Supportive Analysis of Primary Endpoint: Change From Baseline to End of Double-blind Treatment in Sitting Diastolic Blood Pressure at Trough
Description
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.
Time Frame
Baseline (Day -1 to Day 1) and end of double-blind treatment (Day 55 and Day 56)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent prior to any study-mandated procedure No contra-indication to stop (according to label) anti-hypertensive treatment(s) at screening Mild-to-moderate essential hypertension with or without ongoing anti-hypertensive treatment(s): -- Mean (of 5 measurements) sitting diastolic blood pressure (SiDBP) ≥ 90 to < 110 mmHg measured by office blood pressure measurements (OBPM). Women of childbearing potential must have a negative pregnancy test and use of reliable methods of contraception Exclusion Criteria: Severe hypertension (grade 3): mean sitting systolic/diastolic BP (SiSBP/SiDBP; measured by OBPM) ≥ 180/110 mmHg, respectively. Secondary hypertension Known hypertensive retinopathy greater than Keith-Wagener Grade 2 Myocardial infarction, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft within 12 months prior to randomization Unstable angina within 6 months prior to randomization Heart failure New York Heart Association class III and IV Valvular defects (such as severe aortic or mitral valve disease) and/or hemodynamically relevant rhythm disturbances Clinical evidence of cerebrovascular insufficiency or a cerebrovascular accident within 6 months prior to randomization. Subjects working night shifts Body mass index < 20 kg/m2 or > 40 kg/m2 Treatment with any medication which may affect BP (e.g., treatment of psychiatric diseases, ophthalmic preparations) Treatment with strong cytochrome P450 3A4 (CYP3A4) isoenzyme inhibitors or inducers Treatment with guanethidine and/or mineralocorticoid receptor antagonists within 1 month prior to Screening (Visit 1) Treatment with another investigational treatment within 1 month prior to Screening (Visit 1) Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ClinicalTrials
Organizational Affiliation
Idorsia Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Appalachian Cardiovascular Associates
City
Fort Payne
State/Province
Alabama
ZIP/Postal Code
35967
Country
United States
Facility Name
Radiant Research Inc
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Warner Family Practice / Radiant Research Inc
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Phoenix Medical Research Institute LLC
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Advanced Arizona Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Noble Clinical Research LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Desert Sun Clinical Research LLc
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Advanced Research Center Inc
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Med Center
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
John Muir Physician Network Clinical Research Center
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Clinical Trials Research
City
Lincoln
State/Province
California
ZIP/Postal Code
95648
Country
United States
Facility Name
Long Beach Center for Clinical Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
Entertainment Medical Group Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Artemis institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Memorial Research Medical Clinic / Orange County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Empire Clinical Research
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Clinical Research Consulting LLC
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
Facility Name
Chase Medical Research LLC
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Alfieri Cardiology
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
ACRC - Cardiology
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Innovative Research of West Florida INC
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Avail Clinical Research LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Alan Graff, MD, PA
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Gulfcoast Clinical Research Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
AGA Clinical Trials
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Canvas Clinical Research, LLC
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33467
Country
United States
Facility Name
LCC Medical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Allied Biomedical Research Institute, INC
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Southeast Regional Research Group
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31401
Country
United States
Facility Name
Community Clin Res CTR
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46011
Country
United States
Facility Name
Midwest Institute for Clinical Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Heartland Research Associated LLC
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Heartland Research Associates LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Heartland Research Associates LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Avant Research Associates, LLC
City
Crowley
State/Province
Louisiana
ZIP/Postal Code
70526
Country
United States
Facility Name
Best Clinical Trials LLC
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
New Orleans Center for Clinical Research - Nola
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Facility Name
Clinsite LLC
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Primecare Research Associates, LLC
City
Florissant
State/Province
Missouri
ZIP/Postal Code
63031
Country
United States
Facility Name
Clinical Research Advantage, Inc. / Diagnostic Center Of Medicine - Durango
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89117
Country
United States
Facility Name
Premier Research
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08611
Country
United States
Facility Name
Rochester Clinical Research Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Metrolina Internal Medicine/Internal Medicine Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Pharmquest LLC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Peters Medical Research
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27604-1547
Country
United States
Facility Name
Lillestol Research LLC
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Sterling Research Group Ltd.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Aventiv Research Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Dayton Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
Aventiv Research Inc.
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
Facility Name
Oklahoma City Clinic - Edmond / Radiant Research Inc
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
Country
United States
Facility Name
Clinical Research Advantage, Inc. / Oklahoma City Clinic - Midwest City
City
Midwest City
State/Province
Oklahoma
ZIP/Postal Code
73110
Country
United States
Facility Name
Willamette Valley Clinical Studies
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97404
Country
United States
Facility Name
Detweiler Family Medicine and Associates PC
City
Lansdale
State/Province
Pennsylvania
ZIP/Postal Code
19446
Country
United States
Facility Name
Suburban Research Center
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Degarmo Institute of Medical Research
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Volunteer Research Group
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Tekton Research Inc
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Texas Diabetes & Endocrinology
City
Austin
State/Province
Texas
ZIP/Postal Code
78749
Country
United States
Facility Name
Trinity Hypertension & Metabolic Research Institute
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75006
Country
United States
Facility Name
Family Medicine Associates of Texas - ACRC Trials
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75010
Country
United States
Facility Name
Coastal Bend Clinical Research
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78413
Country
United States
Facility Name
TR - Global Medical Research
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Ventavia Research Group, LLC
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Clinical Investigations of Texas
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Avant Research Associates LLC
City
Port Arthur
State/Province
Texas
ZIP/Postal Code
77640
Country
United States
Facility Name
Texas Diabetes & Endocrinology
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Radiant Research Inc
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Bandera Family Health Care
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
Wasatch Clinical Research LLC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Health Research of Hampton Roads
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
National Clinical Research Inc
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Manna Research - Vancouver
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6J 1S3
Country
Canada
Facility Name
Canadian Phase Onwards Inc
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3J 2C5
Country
Canada
Facility Name
Manna Research - Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
Facility Name
Manna Research - Levis
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6W 0M6
Country
Canada
Facility Name
Diex Recherche Montreal Inc
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2Y 1S1
Country
Canada
Facility Name
Diex Recherche Montreal Inc
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2Y 1S1
Country
Canada
Facility Name
Manna Research - Pointe Claire
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 4S3
Country
Canada
Facility Name
Diex Reserach Sherbrooke Inc
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 1Z1
Country
Canada
Facility Name
Cardiology Department Barzilai
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Soroka University Hospital - Hypertension Unit
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
The Hyper Unit, Edith Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Hypertension Treatment Center, Internal Dep, Hadassah
City
Jerusalem
ZIP/Postal Code
91240
Country
Israel
Facility Name
Hypertension And Nephrology Department, Meir Medical Center
City
Kefar Sava
ZIP/Postal Code
44261
Country
Israel
Facility Name
Clinical Research Unit Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Internal Med Department A, Ziv Medical Center
City
Safed
ZIP/Postal Code
13100
Country
Israel
Facility Name
Advanced Medical Concepts, PSC
City
Cidra
ZIP/Postal Code
00739
Country
Puerto Rico
Facility Name
Research & Cardiovascular Corp.
City
Ponce
ZIP/Postal Code
00717
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32063059
Citation
Verweij P, Danaietash P, Flamion B, Menard J, Bellet M. Randomized Dose-Response Study of the New Dual Endothelin Receptor Antagonist Aprocitentan in Hypertension. Hypertension. 2020 Apr;75(4):956-965. doi: 10.1161/HYPERTENSIONAHA.119.14504. Epub 2020 Feb 17.
Results Reference
derived

Learn more about this trial

Dose-finding Study With ACT-132577 (Aprocitentan) in Participants With Essential Hypertension

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