Trial · NCT00112385
Registered outcomes42
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 42
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Occurrence of at Least One Adverse Event | at each visit during the 12 month study | Adverse events (AEs) were assessed using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE). The grade of "mild", "moderate" or "severe" matches with the descriptions from the CTCAE dictionary. In general, a "Mild" AE is asymptomatic; clinical or diagnostic observations only; intervention not indicated. A "Moderate" AE is minimal, local or noninvasive intervention indicated; limiting activities of daily living. A "Severe" AE is medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; |
| Primary | Tolerability | At any point between Baseline (week 0) and the end of the study (Week 52) | The reported tolerability measure was defined as the number of participants that completed the entire 52 week study on their originally assigned treatment. |
| Primary | Average Change in Oral Temperature From Baseline to Week 52 | At Baseline (Week 0) and Week 52 | The subject's oral temperature was measured in degrees Celsius. The average change was determined by subtracting the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40. |
| Primary | Average Change in Respiration Rate From Baseline to Week 52 | At Baseline (Week0) and Week 52 | The subject's respiration rate was measured as number of breaths per minute. The average change was determined by subtracting the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40. |
| Primary | Average Change in Systolic Blood Pressure From Baseline to Week 52 | At Baseline (Week0) and Week 52 | The subject's systolic blood pressure was measured in millimeters of mercury (mmHg). The average value was calculated per treatment group for the Baseline and Week 52 visit based on treatment group. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40. |
| Primary | Average Change in Diastolic Blood Pressure Comparing Baseline to Week 52. | At Baseline (Week0) and Week 52 | The subject's diastolic blood pressure was measured in millimeters of mercury (mm Hg). The average value was calculated for the Baseline and Week 52 visit based on treatment group. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40. |
| Primary | Average Change in Pulse Comparing Baseline to Week 52 | At Baseline (Week0) and Week 52 | The subject's pulse was measured in beats per minute (BPM). The average value was calculated per treatment group for the Baseline and Week 52 visit. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4, 8, 12, 16, 20, 24, 32 and 40. |
| Primary | Average Change in Body Weight in Kilograms (kg) Comparing Baseline to Week 52. | At Baseline (Week0) and Week 52 | The subject's body weight was measured in kilograms(kg). The average value was calculated for each treatment group for the Baseline and Week 52 visits. The average change was determined by subtracting the average value at the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4, 8, 12, 16, 20, 24, 32 and 40. |
| Primary | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Creatine Kinase (CK) Laboratory Values From Baseline to Week 52 | At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant creatine kinase (CK) value if during the course of the study, they had at least one clinically significant CK result that was not present at baseline. Subjects had CK labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. |
| Primary | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Alanine Aminotransferase (ALT) Laboratory Values From Baseline to Week 52 | At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant ALT value if during the course of the study, they had at least one clinically significant ALT result that was not present at baseline. Subjects had ALT labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. |
| Primary | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Gamma-glutamyl Transpeptidase (GGT) Laboratory Values From Baseline to Week 52 | Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant GGT value if during the course of the study, they had at least one clinically significant GGT result that was not present at baseline. Subjects had GGT labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. |
| Primary | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Aldolase Laboratory Values From Baseline to Week 52 | Screening, Baseline (Week0), Week 4, 8,12, 16, 20, 24, 32, 40, and 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant Aldolase value if during the course of the study, they had at least one clinically significant Aldolase result that was not present at baseline. Subjects had Aldolase labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. |
| Primary | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Glucose Laboratory Values From Baseline to Week 52 | At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant Glucose value if during the course of the study, they had at least one clinically significant Glucose result that was not present at baseline. Subjects had Glucose labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. |
| Primary | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Potassium Laboratory Values From Baseline to Week 52 | Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant Potassium value if during the course of the study, they had at least one clinically significant Potassium result that was not present at baseline. Subjects had Potassium labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. |
| Primary | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal White Blood Cell Count (WBC) Values From Baseline to Week 52 | Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant White Blood Cell (WBC) value if during the course of the study, they had at least one clinically significant WBC result that was not present at baseline. Subjects had WBC labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. |
| Primary | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hemoglobin Laboratory Values From Baseline to Week 52 | At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant Hemoglobin value if during the course of the study, they had at least one clinically significant Hemoglobin result that was not present at baseline. Subjects had hemoglobin labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. |
| Primary | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hematocrit Laboratory Values From Baseline to Week 52 | At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant hematocrit value if during the course of the study, they had at least one clinically significant hematocrit result that was not present at baseline. Subjects had hematocrit labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. |
| Primary | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Platelet Counts From Baseline to Week 52 | At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant platelet value if during the course of the study, they had at least one clinically significant platelet result that was not present at baseline. Subjects had platelet labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. |
| Primary | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Leukocyte Values From Baseline to Week 52 | At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least 1 clinically significant urine leukocyte result that was not present at baseline. Subjects had urine leukocyte labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. |
| Primary | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Protein Laboratory Values From Baseline to Week 52 | At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant urine protein result that was not present at baseline. Subjects had urine protein labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. |
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.
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