Trial · NCT00742508
A Phase I/II Clinical Study of SK&F-105517-D in Japanese Patients With Chronic Heart Failure
NCT00742508, Phase 1, Completed, GlaxoSmithKline; results first posted 2010-08-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase I/II Clinical Study of SK&F-105517-D in Japanese Patients With Chronic Heart Failure. Trials, record NCT00742508. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00742508
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase I/II Clinical Study of SK&F-105517-D in Japanese Patients With Chronic Heart Failure
- NCT number
- NCT00742508
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 41 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Heart Failure, Congestive
- Interventions
- SK&F-105517-D 10 mg capsule, Carvedilol-immediate release (IR) 2.5 mg tablet, SK&F-105517-D 20 mg capsule, SK&F-105517-D 40 mg capsule, Carvedilol-IR 10 mg tablet
- First posted
- 2008-08-27
- Last updated
- 2017-08-02
- Results first posted
- 2010-08-19
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events by Severity From Week 0 Through Week 8 (CRV-IR) or Week 14 (SK&F-105517-D) | Treatment Period from Week 0 (Baseline) to Week 8 and 1-week Follow-up Period (Week 9) for CRV-IR; Treatment Period from Week 0 (Baseline) to Week 14 and 1-week Follow-up Period (Week 15) for SK&F-105517-D | Drug-related adverse events (AEs) were defined as AEs that were judged to have a relationship with the investigational product by the investigator (or subinvestigator) with the use of clinical judgment and the Clinical Investigator Brochure to determine the relationship. Refer to adverse event information for type and frequency of adverse events. |
| Primary | Mean Change From Baseline in Albumin and Total Protein at Week 8 | Baseline and Week 8 | Mean change from baseline was calculated as the Week 8 value minus the Baseline value. |
| Primary | Mean Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Creatine Kinase, and Gamma Glutamyl Transferase at Week 8 | Baseline and Week 8 | Mean change from baseline was calculated as the Week 8 value minus the Baseline value |
| Primary | Mean Change From Baseline in Amylase at Week 8 | Baseline and Week 8 | Mean change from baseline was calculated as the Week 8 value minus the Baseline value |
| Primary | Mean Change From Baseline in Total Bilirubin, Creatinine, and Uric Acid at Week 8 | Baseline and Week 8 | Mean change from baseline was calculated as the Week 8 value minus the Baseline value |
| Primary | Mean Change From Baseline in Calcium, Chloride, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen at Week 8 | Baseline and Week 8 | Mean change from baseline was calculated as the Week 8 value minus the Baseline value |
| Primary | Mean Change From Baseline in Creatine Kinase BB Percentage, Creatine Kinase MB Percentage, and Creatine Kinase MM Percentage at Week 8 | Baseline and Week 8 | Mean change from baseline was calculated as the Week 8 value minus the Baseline value. (BB, brain-derived; MB=cardiac muscle-derived; MM=skeletal muscle-derived. |
| Primary | Mean Change From Baseline in Each Type of White Blood Cell (WBC) (Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils) at Week 8 | Baseline and Week 8 | Mean change from baseline was calculated as the Week 8 value minus the Baseline value. |
| Primary | Mean Change From Baseline in Hemoglobin and Mean Corpuscular Hemoglobin Concentration at Week 8 | Baseline and Week 8 | Mean change from baseline was calculated as the Week 8 value minus the Baseline value. |
| Primary | Mean Change From Baseline in Hematocrit at Week 8 | Baseline and Week 8 | Mean change from baseline was calculated as the Week 8 value minus the Baseline value. |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events by Severity From Week 0 Through Week 8 (CRV-IR) or Week 14 (SK&F-105517-D) | Treatment Period from Week 0 (Baseline) to Week 8 and 1-week Follow-up Period (Week 9) for CRV-IR; Treatment Period from Week 0 (Baseline) to Week 14 and 1-week Follow-up Period (Week 15) for SK&F-105517-D | Safety Population: all participants who received at least one dose of the investigational product | participants | NUMBER |
| SECONDARY | Maximum Plasma Concentration (Cmax) and Trough Plasma Concentration (Cmin) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8 | Week 8 | PK Parameter Population: total of 13 participants, including 3 who gave samples in group F at Week 8 in CRV-IR group; total of 15 participants, including 4 who gave samples at Week 8 in the SK\&F-105517-D group) | nanograms per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC0-24) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8 | Week 8 | Pharmacokinetic (PK) Parameter Population: all participants who received the study drug at each dose level and provided sufficient PK concentration data and the data for estimation of PK parameters (total of 13 participants, 3 gave samples at Week 8 in CRV-IR group; total of 15 participants, 4 gave samples at Week 8 in the SK\&F-105517-D group) | hours * nanograms per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Time of Maximal Plasma Concentration (Tmax) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8 | Week 8 | PK Parameter Population: total of 13 participants, including 3 in group F who gave samples at Week 8 in the CRV-IR group; total of 15 participants, including 4 in group C who gave samples at Week 8 in the SK\&F-105517-D group | hours | MEDIAN |
| SECONDARY | Adjusted Mean Change From Baseline in Systolic Blood Pressure at Week 8 | Baseline and Week 8 | Pharmacodynamic (PD) Population: all participants measurable at the PD endpoints (18 participants at baseline and 3 participants at Week 8 in CRV-IR group, 19 participants at baseline and 4 participants at Week 8 in SK\&F-105517-D group) | millimeters of mercury (mmHg) | MEAN |
| PRIMARY | Mean Change From Baseline in Albumin and Total Protein at Week 8 | Baseline and Week 8 | Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK\&F-105517-D group. Some participants in each treatment arm withdrew prematurely. | grams per liter (g/L) | MEAN |
| PRIMARY | Mean Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Creatine Kinase, and Gamma Glutamyl Transferase at Week 8 | Baseline and Week 8 | Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK\&F-105517-D group. Some participants in each treatment arm withdrew prematurely. | international units per liter (IU/L) | MEAN |
| PRIMARY | Mean Change From Baseline in Amylase at Week 8 | Baseline and Week 8 | Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK\&F-105517-D group. Some participants in each treatment arm withdrew prematurely. | units per liter (U/L) | MEAN |
| PRIMARY | Mean Change From Baseline in Total Bilirubin, Creatinine, and Uric Acid at Week 8 | Baseline and Week 8 | Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK\&F-105517-D group. Some participants in each treatment arm withdrew prematurely. | micromoles per liter (umol/L) | MEAN |
| PRIMARY | Mean Change From Baseline in Calcium, Chloride, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen at Week 8 | Baseline and Week 8 | Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK\&F-105517-D group. Some participants in each treatment arm withdrew prematurely. | millimoles per liter (mmol/L) | MEAN |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group290
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events by Severity From Week 0 Through Week 8 (CRV-IR) or Week 14 (SK&F-105517-D) | CRV-IR | Severe | 0 | participants | |
| Number of Participants With Adverse Events by Severity From Week 0 Through Week 8 (CRV-IR) or Week 14 (SK&F-105517-D) | SK&F-105517-D | Severe | 1 | participants | |
| Number of Participants With Adverse Events by Severity From Week 0 Through Week 8 (CRV-IR) or Week 14 (SK&F-105517-D) | CRV-IR | Moderate | 2 | participants | |
| Number of Participants With Adverse Events by Severity From Week 0 Through Week 8 (CRV-IR) or Week 14 (SK&F-105517-D) | SK&F-105517-D | Moderate | 5 | participants | |
| Number of Participants With Adverse Events by Severity From Week 0 Through Week 8 (CRV-IR) or Week 14 (SK&F-105517-D) | CRV-IR | Mild | 9 | participants | |
| Number of Participants With Adverse Events by Severity From Week 0 Through Week 8 (CRV-IR) or Week 14 (SK&F-105517-D) | SK&F-105517-D | Mild | 10 | participants | |
| Number of Participants With Adverse Events by Severity From Week 0 Through Week 8 (CRV-IR) or Week 14 (SK&F-105517-D) | CRV-IR | Severe (drug-related) | 0 | participants | |
| Number of Participants With Adverse Events by Severity From Week 0 Through Week 8 (CRV-IR) or Week 14 (SK&F-105517-D) | SK&F-105517-D | Severe (drug-related) | 1 | participants | |
| Number of Participants With Adverse Events by Severity From Week 0 Through Week 8 (CRV-IR) or Week 14 (SK&F-105517-D) | CRV-IR | Moderate (drug-related) | 2 | participants | |
| Number of Participants With Adverse Events by Severity From Week 0 Through Week 8 (CRV-IR) or Week 14 (SK&F-105517-D) | SK&F-105517-D | Moderate (drug-related) | 3 | participants |
1 to 10 of 290Source ClinicalTrials.gov
See all 290 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 8-Week Primary Evaluation Period | STARTED | CRV-IR | 22 | |
| 8-Week Primary Evaluation Period | STARTED | SK&F-105517-D | 19 | |
| 8-Week Primary Evaluation Period | COMPLETED | CRV-IR | 11 | |
| 8-Week Primary Evaluation Period | COMPLETED | SK&F-105517-D | 8 | |
| 8-Week Primary Evaluation Period | NOT COMPLETED | CRV-IR | 11 | |
| 8-Week Primary Evaluation Period | NOT COMPLETED | SK&F-105517-D | 11 | |
| 4-Week Exploratory Evaluation Period | STARTED | CRV-IR | 0 | |
| 4-Week Exploratory Evaluation Period | STARTED | SK&F-105517-D | 8 | |
| 4-Week Exploratory Evaluation Period | COMPLETED | CRV-IR | 0 | |
| 4-Week Exploratory Evaluation Period | COMPLETED | SK&F-105517-D | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events82
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | CRV-IR | 2 | 22 | |
| other | Diarrhoea | Gastrointestinal disorders | SK&F-105517-D | 2 | 19 | |
| other | Nasopharyngitis | Infections and infestations | CRV-IR | 2 | 22 | |
| other | Nasopharyngitis | Infections and infestations | SK&F-105517-D | 2 | 19 | |
| other | Dermatitis contact | Skin and subcutaneous tissue disorders | CRV-IR | 1 | 22 | |
| other | Dermatitis contact | Skin and subcutaneous tissue disorders | SK&F-105517-D | 2 | 19 | |
| other | Dizziness | Nervous system disorders | CRV-IR | 1 | 22 | |
| other | Dizziness | Nervous system disorders | SK&F-105517-D | 2 | 19 | |
| other | Blood uric acid increased | Investigations | CRV-IR | 1 | 22 | |
| other | Blood uric acid increased | Investigations | SK&F-105517-D | 1 | 19 |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CRV-IR | ||
| Total, all-cause mortality | SK&F-105517-D | ||
| Total, other adverse events | CRV-IR | 11 | 22 |
| Total, other adverse events | SK&F-105517-D | 15 | 19 |
| Total, serious adverse events | CRV-IR | 1 | 22 |
| Total, serious adverse events | SK&F-105517-D | 3 | 19 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22240593 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| CRV-IR vs SK&F-105517-D: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00742508
GET https://conductscience.org/api/trials/v1/NCT00742508/registered?page=2