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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Matching Placebo |
|
| 2 | Experimental |
| |
| 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PS433540 | Drug | 200mg capsule, once daily for 28 days |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure | 4 weeks of treatment with PS43540 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel M Neutel, MD | Integrium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Premiere Pharmaceutical Research, LLC | Tempe | Arizona | 85282 | United States | ||
| Clinical Trials Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1- Placebo | Placebo |
| FG001 | 2- PS433540 200mg | 200mg daily for 4 weeks |
| FG002 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
placebo capsule, once daily for 28 days |
|
| PS433540 | Drug | 500mg capsule, once daily for 28 days |
|
| Lincoln |
| California |
| 95648 |
| United States |
| Long Beach Center for Clinical Research | Long Beach | California | 90806 | United States |
| National Research Institute | Los Angeles | California | 90057 | United States |
| Sacramento Research Medical Group | Sacramento | California | 95825 | United States |
| Orange County Research Center | Tustin | California | 92780 | United States |
| Westlake Medical Center | Westlake Village | California | 91361 | United States |
| University Clinical Research Deland, LLC | DeLand | Florida | 32720 | United States |
| Alan Graff, MD PA | Fort Lauderdale | Florida | 33308 | United States |
| Cedar Crosse Research Center | Chicago | Illinois | 60607 | United States |
| Orland Primary Care Specialists | Orland Park | Illinois | 60467 | United States |
| MD Medical Research | Oxon Hill | Maryland | 20745 | United States |
| Lindner Clinical Trial Center | Cincinnati | Ohio | 45219 | United States |
| Punzi Medical Center | Carrolton | Texas | 75006 | United States |
| Gemini Scientific | Madison | Wisconsin | 53719 | United States |
| 3- PS433540 500mg |
500mg once daily for 4 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1- Placebo | Placebo |
| BG001 | 2- PS433540 200mg | 200mg daily for 4 weeks |
| BG002 | 3- PS433540 500mg | 500mg once daily for 4 weeks |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure | Posted | Mean | 95% Confidence Interval | mmHg | 4 weeks of treatment with PS43540 |
|
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| Secondary | Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure | Not Posted | 4 weeks of treatment with PS43540 | |||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Seated Systolic and Diastolic Blood Pressure | Not Posted | 4 weeks of treatment with PS43540 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1- Placebo | Placebo | 1 | 36 | 9 | 36 | ||
| EG001 | 2- PS433540 200mg | 200mg daily for 4 weeks | 1 | 39 | 8 | 39 | ||
| EG002 | 3- PS433540 500mg | 500mg once daily for 4 weeks | 0 | 38 | 10 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | Cardiac disorders | MedDRA v9.1 | Systematic Assessment | Syncope and confusional state in placebo patient that led to withdrawal |
|
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v9.1 | Systematic Assessment | Reported prior to subject randomization |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Blood Pressure Increase | Investigations | MedDRA (9.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Oedema Peripheral | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ram Kapil, PhD/ Sr. Director, Clinical Pharmacology | Ligand Pharmaceuticals, Inc. | 858-550-7603 | rkapil@ligand.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|