Essential Hypertension
Conditions
Keywords
Hypertension, Essential Hypertension
Brief summary
The purpose of the study is to evaluate the safety and efficacy of a fixed-dose combination drug compared to two other drugs (monotherapies) in controlling hypertension.
Interventions
DRUGXOMA 985
PERa/AMLb capsule taken once daily by mouth for six weeks
AMLb capsule taken once daily by mouth for six weeks
PERe capsule taken once daily by mouth for six weeks
Sponsors
Symplmed Pharmaceuticals LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Essential hypertension * For female subjects, a negative serum pregnancy test * Ability to provide written informed consent
Exclusion criteria
* Night shift workers whose work hours include midnight to 4:00 a.m. * Secondary hypertension * An arm size that precludes the use of the digital blood pressure monitor cuff (arm size \> 42 cm) * Renal dysfunction, severe renal impairment, bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, subjects with only 1 kidney, or post-renal transplant subjects * Female subjects who are pregnant, planning to become pregnant * History of malignancy within 5 years * Primary aldosteronism * Heart failure (NYHA functional class 3-4), hypertrophic obstructive cardiomyopathy, or hemodynamically relevant stenosis of the aortic or mitral valve * Significant cardiac arrhythmias, MI, stroke, CABG, PTCA, unstable angina * Known hypersensitivity to any component of the study drugs Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP). | Day 0 to Day 42 |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP). | Day 0 to Day 42 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| XOMA 985 fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)
XOMA 985: PERa/AMLb capsule taken once daily by mouth for six weeks | 279 |
| Amlodipine Besylate (AMLb) Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks | 280 |
| Perindopril Erbumine (PERe) Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks | 278 |
| Total | 837 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 10 | 12 | 12 |
| Overall Study | Lost to Follow-up | 6 | 6 | 4 |
| Overall Study | Other | 2 | 3 | 7 |
| Overall Study | Physician Decision | 1 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 7 | 6 | 8 |
Baseline characteristics
| Characteristic | Amlodipine Besylate (AMLb) | Perindopril Erbumine (PERe) | XOMA 985 | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 24 Participants | 18 Participants | 60 Participants |
| Age, Categorical Between 18 and 65 years | 262 Participants | 254 Participants | 261 Participants | 777 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 43 Participants | 52 Participants | 47 Participants | 142 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 237 Participants | 226 Participants | 232 Participants | 695 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 96 participants | 96 participants | 95 participants | 287 participants |
| Race/Ethnicity, Customized Non-black | 184 participants | 182 participants | 184 participants | 550 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 96 Participants | 96 Participants | 95 Participants | 287 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 181 Participants | 180 Participants | 179 Participants | 540 Participants |
| Region of Enrollment United States | 280 participants | 278 participants | 279 participants | 837 participants |
| Sex: Female, Male Female | 130 Participants | 143 Participants | 134 Participants | 407 Participants |
| Sex: Female, Male Male | 150 Participants | 135 Participants | 145 Participants | 430 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 75 / 279 | 68 / 280 | 53 / 278 |
| serious Total, serious adverse events | 1 / 279 | 3 / 280 | 2 / 278 |
Outcome results
Primary
Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP).
Time frame: Day 0 to Day 42
Population: The Analysis Population for the Primary Outcome (Change from baseline to end of treatment in the mean seated trough cuff diastolic blood pressure (DBP)) consists of the Intent-to-treat population for the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XOMA 985 | Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP). | -15.7 mmHg | Standard Deviation 8.38 |
| Amlodipine Besylate (AMLb) | Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP). | -13.2 mmHg | Standard Deviation 8.33 |
| Perindopril Erbumine (PERe) | Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP). | -9.5 mmHg | Standard Deviation 8.77 |
p-value: 0.025ANCOVA
Secondary
Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP).
Time frame: Day 0 to Day 42
Population: The Analysis Population for the Secondary Outcome (Change from baseline to end of treatment in the mean seated trough cuff systolic blood pressure (SBP)) consists of the Intent-to-treat population for the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XOMA 985 | Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP). | -23.4 mmHg | Standard Deviation 13.86 |
| Amlodipine Besylate (AMLb) | Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP). | -19.6 mmHg | Standard Deviation 15.62 |
| Perindopril Erbumine (PERe) | Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP). | -13.4 mmHg | Standard Deviation 14.66 |
p-value: 0.025ANCOVA