Hypertension
Conditions
Keywords
hypertension, high blood pressure
Brief summary
The purpose of the study is to see if PS433540 lowers blood pressure better than placebo and to see how safe PS433540 is compared to placebo.
Interventions
DRUGPS433540
200mg capsule, once daily for 28 days
DRUGplacebo
placebo capsule, once daily for 28 days
Sponsors
Ligand Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Males or females 30 - 80 years * Mean seated Systolic Blood Pressure (SBP) ≥ 150 - ≤ 179 mmHg and mean seated DBP \< 110 mmHg at two consecutive qualifying visits. The mean difference in SBP between the two consecutive qualifying visits must be ≤ 10 mmHg. * Mean daytime (8AM - 4PM) ambulatory SBP must be between ≥ 140 - ≤ 179 mmHg and mean daytime (8AM - 4PM) Diastolic Blood Pressure (DBP) ≤ 110 mmHg * Subjects must have a usual daytime schedule. Night shift workers are excluded from participation. * Women of child-bearing potential (WOCBP) and male subjects must use two reliable forms of contraception if sexually active. Alternatively, female subjects must be postmenopausal (for at least 1 year)
Exclusion criteria
* Subjects with serious disorders which may limit the ability to evaluate the efficacy or safety of PS433540, including cardiovascular, renal (including the absence of one kidney), pulmonary, hepatic, gastrointestinal (including clinically significant malabsorption), endocrine/metabolic, hematologic/oncologic (including an active malignancy other than basal cell carcinoma), neurologic and psychiatric diseases. * Subjects with a history of myocardial infarction, angina, coronary angioplasty, bypass surgery or New York Heart Association (NYHA) class II-IV heart failure within the last 6 months. * Subjects with a history of cerebrovascular accident or transient ischemic attack within the last 1 year. * Subjects with diabetes mellitus (type I and type II).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure | 4 weeks of treatment with PS43540 |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure | 4 weeks of treatment with PS43540 |
| Change From Baseline in Mean Seated Systolic and Diastolic Blood Pressure | 4 weeks of treatment with PS43540 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1- Placebo Placebo | 36 |
| 2- PS433540 200mg 200mg daily for 4 weeks | 39 |
| 3- PS433540 500mg 500mg once daily for 4 weeks | 38 |
| Total | 113 |
Baseline characteristics
| Characteristic | 2- PS433540 200mg | 3- PS433540 500mg | 1- Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 7 Participants | 6 Participants | 25 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 31 Participants | 30 Participants | 88 Participants |
| Age Continuous | 59.1 years STANDARD_DEVIATION 8.72 | 56.8 years STANDARD_DEVIATION 9.87 | 58.4 years STANDARD_DEVIATION 7.94 | 58.1 years STANDARD_DEVIATION 8.84 |
| Region of Enrollment United States | 39 participants | 38 participants | 36 participants | 113 participants |
| Sex: Female, Male Female | 18 Participants | 10 Participants | 12 Participants | 40 Participants |
| Sex: Female, Male Male | 21 Participants | 28 Participants | 24 Participants | 73 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 | 9 / 36 | 8 / 39 | 10 / 38 |
| serious Total, serious adverse events | 1 / 36 | 1 / 39 | 0 / 38 |
Outcome results
Primary
Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure
Time frame: 4 weeks of treatment with PS43540
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 1- Placebo | Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure | -0.3 mmHg |
| 2- PS433540 200mg | Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure | -11.9 mmHg |
| 3- PS433540 500mg | Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure | -15.3 mmHg |
Secondary
Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure
Time frame: 4 weeks of treatment with PS43540
Secondary
Change From Baseline in Mean Seated Systolic and Diastolic Blood Pressure
Time frame: 4 weeks of treatment with PS43540