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Randomized, double-blind, parallel group, multicenter study of subjects with Stage 1 or 2 essential hypertension who are not at target blood pressure (<140/90mmHg) at Baseline. Subjects will be randomized to receive either carvedilol CR + lisinopril or lisinopril + placebo. Subjects will be uptitrated over a 6 week period until target blood pressure (<140/90mmHg) is met. The primary objective of the study is to compare the proportion of subjects who achieve target blood pressure after 6 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| carvedilol CR + lisinopril | Experimental |
| |
| lisinopril + placebo | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carvedilol controlled release/lisinopril | Drug | carvedilol CR + lisinopril given as separate pills |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Mean Sitting Cuff Blood Pressure <140/90 mmHg at the End of 6 Weeks of Treatment | Sitting cuff blood pressure was calculated as the mean of three measurements taken approximately 2 minutes apart, and before the morning dose. | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Sitting Systolic Blood Pressure (sSBP) and Sitting Diastolic Blood Pressure (sDBP) at Week 6 | Mean change was calculated as Week 6 values minus Baseline values. | Baseline and Week 6 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Mobile | Alabama | 36617 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | GSK has submitted manuscripts of these study results to peer-reviewed scientific journals which were not accepted for publication. GSK is providing the attached study results summary with a conclusion. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| COR111096 | Statistical Analysis Plan | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lisinopril | Lisinopril monotherapy (10, 20, or 40 mg once daily) |
| FG001 | Carvedilol CR + Lisinopril | Carvedilol controlled release (CR) + lisinopril (20 + 10, 20 + 20, or 40 + 20 mg once daily) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| lisinopril + placebo | Drug | lisinopril plus placebo to match carvedilol CR |
|
| Chandler |
| Arizona |
| 77030 |
| United States |
| GSK Investigational Site | Glendale | Arizona | 85308 | United States |
| GSK Investigational Site | Goodyear | Arizona | 85395 | United States |
| GSK Investigational Site | Litchifield Park/Arizona | Arizona | 85340 | United States |
| GSK Investigational Site | Phoenix | Arizona | 85032 | United States |
| GSK Investigational Site | Tucson | Arizona | 85745 | United States |
| GSK Investigational Site | Anaheim | California | 92801 | United States |
| GSK Investigational Site | Beuna Park | California | 90620 | United States |
| GSK Investigational Site | Fountain Valley | California | 92708 | United States |
| GSK Investigational Site | Poway | California | 92064 | United States |
| GSK Investigational Site | San Ramon | California | 94583 | United States |
| GSK Investigational Site | Tustin | California | 92780 | United States |
| GSK Investigational Site | Vista | California | 92081 | United States |
| GSK Investigational Site | Coral Gables | Florida | 33134 | United States |
| GSK Investigational Site | DeLand | Florida | 32720 | United States |
| GSK Investigational Site | Fort Lauderdale | Florida | 33308 | United States |
| GSK Investigational Site | Hollywood | Florida | 33023 | United States |
| GSK Investigational Site | Miami | Florida | 33156 | United States |
| GSK Investigational Site | Pembroke Pines | Florida | 33024 | United States |
| GSK Investigational Site | Tamarac | Florida | 33321 | United States |
| GSK Investigational Site | West Palm Beach | Florida | 33409 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30342 | United States |
| GSK Investigational Site | Savannah | Georgia | 31406 | United States |
| GSK Investigational Site | Nampa | Idaho | 83686 | United States |
| GSK Investigational Site | Aurora | Illinois | 60504 | United States |
| GSK Investigational Site | Chicago | Illinois | 60607 | United States |
| GSK Investigational Site | Gillespie | Illinois | 62033 | United States |
| GSK Investigational Site | Elkhart | Indiana | 46514 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46250 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46260 | United States |
| GSK Investigational Site | Wichita | Kansas | 67205 | United States |
| GSK Investigational Site | Wichita | Kansas | 67207 | United States |
| GSK Investigational Site | Paducah | Kentucky | 42003 | United States |
| GSK Investigational Site | Slidell | Louisiana | 70458 | United States |
| GSK Investigational Site | Columbia | Maryland | 21045 | United States |
| GSK Investigational Site | Butte | Montana | 59701 | United States |
| GSK Investigational Site | Omaha | Nebraska | 68134 | United States |
| GSK Investigational Site | Las Vegas | Nevada | 89016 | United States |
| GSK Investigational Site | Las Vegas | Nevada | 89119 | United States |
| GSK Investigational Site | Albuquerque | New Mexico | 87102 | United States |
| GSK Investigational Site | Buffalo | New York | 14209 | United States |
| GSK Investigational Site | Buffalo | New York | 14215 | United States |
| GSK Investigational Site | East Syracuse | New York | 13057 | United States |
| GSK Investigational Site | New York | New York | 10075 | United States |
| GSK Investigational Site | Westfield | New York | 14787 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27609 | United States |
| GSK Investigational Site | Fargo | North Dakota | 58103 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45219 | United States |
| GSK Investigational Site | Corvallis | Oregon | 97330 | United States |
| GSK Investigational Site | Altoona | Pennsylvania | 16602 | United States |
| GSK Investigational Site | Havertown | Pennsylvania | 19083 | United States |
| GSK Investigational Site | Jersey Shore | Pennsylvania | 17740 | United States |
| GSK Investigational Site | Lansdale | Pennsylvania | 19446 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19154 | United States |
| GSK Investigational Site | Columbia | South Carolina | 29201 | United States |
| GSK Investigational Site | Columbia | South Carolina | 29204 | United States |
| GSK Investigational Site | Manning | South Carolina | 29102 | United States |
| GSK Investigational Site | Johnson City | Tennessee | 37601 | United States |
| GSK Investigational Site | Austin | Texas | 78705 | United States |
| GSK Investigational Site | Georgetown | Texas | 78626 | United States |
| GSK Investigational Site | Grand Prairie | Texas | 75052 | United States |
| GSK Investigational Site | Houston | Texas | 77081 | United States |
| GSK Investigational Site | San Antonio | Texas | 78224 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Sugar Land | Texas | 77479 | United States |
| GSK Investigational Site | Draper | Utah | 84020 | United States |
| GSK Investigational Site | Magna | Utah | 84044 | United States |
| GSK Investigational Site | Salt Lake City | Utah | 84109 | United States |
| GSK Investigational Site | Salt Lake City | Utah | 84121 | United States |
| GSK Investigational Site | Sandy City | Utah | 84094 | United States |
| GSK Investigational Site | Bellingham/Washington | Washington | 98226 | United States |
| GSK Investigational Site | Gig Harbor | Washington | 98335 | United States |
| GSK Investigational Site | Olympia | Washington | 98502-8151 | United States |
| GSK Investigational Site | Tacoma | Washington | 98405 | United States |
| GSK Investigational Site | Beloit | Wisconsin | 53511 | United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| COR111096 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| COR111096 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| COR111096 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| COR111096 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| COR111096 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| COR111096 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| COMPLETED |
|
| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lisinopril | Lisinopril monotherapy (10, 20, or 40 mg once daily) |
| BG001 | Carvedilol CR + Lisinopril | Carvedilol controlled release (CR) + lisinopril (20 + 10, 20 + 20, or 40 + 20 mg once daily) |
| BG002 | 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||
| Baseline Blood Pressure | Mean | Standard Deviation | mm/Hg |
|
| 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 | Number of Participants With Mean Sitting Cuff Blood Pressure <140/90 mmHg at the End of 6 Weeks of Treatment | Sitting cuff blood pressure was calculated as the mean of three measurements taken approximately 2 minutes apart, and before the morning dose. | Intent to Treat Efficacy (ITTE) Population: all randomized participants with efficacy (vital signs) data after a minimum of 4 weeks of treatment | Posted | Number | Participants | Week 6 |
|
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Sitting Systolic Blood Pressure (sSBP) and Sitting Diastolic Blood Pressure (sDBP) at Week 6 | Mean change was calculated as Week 6 values minus Baseline values. | ITTE | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 6 |
|
|
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The frequency threshold for reporting Other Adverse Events is 1% in either treatment group.
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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 | Lisinopril | Lisinopril monotherapy (10, 20, or 40 mg once daily) | 2 | 50 | ||||
| EG001 | Carvedilol CR + Lisinopril | Carvedilol controlled release (CR) + lisinopril (20 + 10, 20 + 20, or 40 + 20 mg once daily) | 3 | 54 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Hyperhydrosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017706 | Lisinopril |
| ID | Term |
|---|---|
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Male |
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| American Indian or Alaska Native |
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| Japanese/East Asian/South East Asian Heritage |
|
| Mixed Asian Heritage |
|
| White |
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| AA/AH & American Indian or Alaska Native |
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| AA/AH & American Indian or Alaska Native & White |
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| AA/AH & White |
|
| Baseline Sitting Diastolic Blood Pressure (DBP) |
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|