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Poor enrollment
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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Evaluate effectiveness of Carvedilol CR on Micro T-Wave Alternans in high risk hypertensives
The effect of Carvedilol CR on Micro T-Wave Alternans will be assessed in 30 hypertensives with stage 4 or 5 chronic kidney disease utilizing a cross-over design and contrasting no treatment against active treatment periods of 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Study Participants | Active Comparator | All enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carvedilol and Placebo | Other | All enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately. |
| Measure | Description | Time Frame |
|---|---|---|
| Micro T- Wave Alternans | week 1, 8, 11, 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Oxidized LDL | week 1, 8, 11, 18 | |
| Interleukin-6 | week 1, 8, 11, 18 | |
| Plasma C-reactive Protein |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Cooper,, MD | University of Toledo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Toledo, Health Science Campus | Toledo | Ohio | 43606 | United States | ||
| Site Rhode Island Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Carvedilol Then Placebo | Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following. Carvedilol: Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following. |
| FG001 | Placebo Then Study Drug | Subjects will receive placebo for 8 weeks then be given study drug for 8 more. Placebo: Subjects will receive placebo for 8 weeks then be given study drug for 8 more. |
| FG002 | All Participants | All enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Carvedilol Then Placebo | Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following. Carvedilol: Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following. |
| BG001 | Placebo Then Study Drug |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Micro T- Wave Alternans | Posted | week 1, 8, 11, 18 |
|
|
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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 | Carvedilol Then Placebo | Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following. Carvedilol: Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low Blood Pressure | Cardiac disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders |
Early termination due to poor enrollment leading to small number of subjects to be analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Cooper, MD | The University of Toledo, HSC | 419.383.6030 | christopher.cooper@utoledo.edu |
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| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D007674 | Kidney Diseases |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000077261 | Carvedilol |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| week 1, 8, 11, 18 |
| Plasma Cardiac Troponin T | week 1, 8, 11, 18 |
| Plasma NT-pro BNP | week 1, 8, 11, 18 |
| Plasma F2-isoprostanes | week 1, 8, 11, 18 |
| Providence |
| Rhode Island |
| 02903 |
| United States |
Subjects will receive placebo for 8 weeks then be given study drug for 8 more. Placebo: Subjects will receive placebo for 8 weeks then be given study drug for 8 more. |
| BG002 | All Study Participants | All enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Number | participants |
|
| Gender | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
| Secondary | Oxidized LDL | Not Posted | week 1, 8, 11, 18 |
| Secondary | Interleukin-6 | Not Posted | week 1, 8, 11, 18 |
| Secondary | Plasma C-reactive Protein | Not Posted | week 1, 8, 11, 18 |
| Secondary | Plasma Cardiac Troponin T | Not Posted | week 1, 8, 11, 18 |
| Secondary | Plasma NT-pro BNP | Not Posted | week 1, 8, 11, 18 |
| Secondary | Plasma F2-isoprostanes | Not Posted | week 1, 8, 11, 18 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Placebo Then Study Drug | Subjects will receive placebo for 8 weeks then be given study drug for 8 more. Placebo: Subjects will receive placebo for 8 weeks then be given study drug for 8 more. | 0 | 0 | 0 | 0 |
| EG002 | All Study Participants | All enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately | 2 | 6 | 6 | 6 |
| Hypoglycemia | Endocrine disorders |
|
| Fluid Retention | Cardiac disorders |
|
| Shortness of Breath | Cardiac disorders |
|
| Headache | General disorders |
|
| Hypoglycemia | Endocrine disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Dry Cough | General disorders |
|
| Dry Mouth | General disorders |
|
| Pain at Dialysis Catheter Site | Renal and urinary disorders |
|
| Right Groin Pain | Cardiac disorders |
|
| Lower Extremity Angiogram | Vascular disorders |
|
| Dialysis Catheter Placed | Renal and urinary disorders |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020005 |
| Propanols |
| D000588 | Amines |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |