Trial · NCT00742508
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| 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. |
| Primary | Mean Change From Baseline in Platelet Count and White Blood Cell Count 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 Red Blood Cell Count 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 Mean Corpuscular Hemoglobin 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 Mean Corpuscular Volume at Week 8 | Baseline and Week 8 | Mean change from baseline was calculated as the Week 8 value minus the Baseline value. |
| Primary | Number of Participants With the Indicated Urinalysis Dipstick Results at Baseline and Week 8 | Baseline and Week 8 | Dipstick test values: Negative (-), Traces (+-), +1, +2, +3. +4. Normal ranges (qualitative): protein, - or +-; glucose, - or +-; occult blood, -; ketones, -. |
| Primary | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure 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 Heart Rate 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 Weight at Week 8 | Baseline and Week 8 | Mean change from baseline was calculated as the Week 8 value minus the Baseline value. |
| Primary | Number of Participants With the Indicated Electrocardiogram Findings at Baseline and Week 8 | Baseline and Week 8 | There are 3 categories for electrocardiogram (ECG) findings: normal; abnormal, not clinically significant; and abnormal, clinically significant. Each of the findings was classified by the investigator according to whether it was normal. Abnormal ECGs were further classified according to whether they were felt to be clinically significant in the medical and scientific judgment of the investigator. |
| Primary | Cardiothoracic Ratio at Baseline and Week 8 | Baseline and Week 8 | Cardiothoracic ratio is a marker of the degree of heart enlargement and was measured by chest X-ray. It is shown as the ratio of the transverse diameter of the heart to the transverse diameter of the thorax, and is measured as a percentage. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT00742508/registered