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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XOMA 985 | Experimental | fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb) |
|
| Amlodipine Besylate (AMLb) | Active Comparator |
| |
| Perindopril Erbumine (PERe) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XOMA 985 | Drug | PERa/AMLb capsule taken once daily by mouth for six weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP). | Day 0 to Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP). | Day 0 to Day 42 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville | Alabama | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Amlodipine Besylate (AMLb) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Amlodipine Besylate |
| Drug |
AMLb capsule taken once daily by mouth for six weeks |
|
| Perindopril Erbumine | Drug | PERe capsule taken once daily by mouth for six weeks |
|
| Muscle Shoals |
| Alabama |
| United States |
| Glendale | Arizona | United States |
| Greenbrae | California | United States |
| Los Angeles | California | United States |
| Santa Ana | California | United States |
| Denver | Colorado | United States |
| DeLand | Florida | United States |
| Fort Lauderdale | Florida | United States |
| Miami | Florida | United States |
| Palm Harbor | Florida | United States |
| Port Orange | Florida | United States |
| Marietta | Georgia | United States |
| Gurnee | Illinois | United States |
| Indianapolis | Indiana | United States |
| Wichita | Kansas | United States |
| Louisville | Kentucky | United States |
| Metairie | Louisiana | United States |
| Auburn | Maine | United States |
| Baltimore | Maryland | United States |
| Olive Branch | Mississippi | United States |
| Butte | Montana | United States |
| Berlin | New Jersey | United States |
| Greensboro | North Carolina | United States |
| Hickory | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Columbus | Ohio | United States |
| Kettering | Ohio | United States |
| Lyndhurst | Ohio | United States |
| Marion | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Tulsa | Oklahoma | United States |
| Eugene | Oregon | United States |
| Mt. Pleasant | South Carolina | United States |
| Simpsonville | South Carolina | United States |
| Bristol | Tennessee | United States |
| Austin | Texas | United States |
| Corpus Christi | Texas | United States |
| Dallas | Texas | United States |
| Fort Worth | Texas | United States |
| Houston | Texas | United States |
| Katy | Texas | United States |
| San Antonio | Texas | United States |
| Salt Lake City | Utah | United States |
| Norfolk | Virginia | United States |
| Richmond | Virginia | United States |
Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks
| FG002 | Perindopril Erbumine (PERe) | Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks |
| COMPLETED |
|
| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Amlodipine Besylate (AMLb) | Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks |
| BG002 | Perindopril Erbumine (PERe) | Perindopril Erbumine: PERe capsule taken once daily by mouth for six 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 |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | 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 to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP). | 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 | Posted | Mean | Standard Deviation | mmHg | Day 0 to Day 42 |
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| Secondary | Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP). | 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 | Posted | Mean | Standard Deviation | mmHg | Day 0 to Day 42 |
|
|
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AE reporting began with Visit 1 and continued through 14 days after last dose, unless an unresolved AE was still being followed. At each evaluation, the Investigator determined whether any AEs occurred based on the criteria and definition of an AE or SAE. AEs may have been directly observed, elicited by Investigator, or volunteered by subjects.
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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 | 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 | 1 | 279 | 75 | 279 | ||
| EG001 | Amlodipine Besylate (AMLb) | Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks | 3 | 280 | 68 | 280 | ||
| EG002 | Perindopril Erbumine (PERe) | Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks | 2 | 278 | 53 | 278 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lip Swelling | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gastrointestinal Hemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Edema peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Alanine amniotransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Aspartate amniotransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Blood potassium increased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeff Feldstein, Sr. Vice President and CMO | Symplmed Pharmaceuticals LLC | 888-552-9769 | feldstein@symplmed.com |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017311 | Amlodipine |
| D020913 | Perindopril |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Non-black |
|
|
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