Trial · NCT02553265
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Reported Adverse Events Related to Study Drug | Up to 90 days | Adverse events defined as: a change in a patient's baseline condition including intercurrent illnesses irrespective of the relationship to carbidopa treatment. This will be monitored primarily with phone calls at weekly intervals. In addition, patients will be asked about adverse events while at the office. Patients will also fill a daily diary with a specific prompts to note any adverse events. |
| Primary | Number of Participants With Significant Changes in Body Mass That Resulted in Discontinuation From the Study. | Up to 90 days | Body mass measured in kg |
| Primary | Number of Participants With Abnormal Electrocardiographic Interval Patterns | Up to 90 days | Clinically significant changes in the intervals of characteristic electrocardiographic patterns |
| Primary | Average Systolic Blood Pressure Variability (Daytime) | up to Week 14 | Patients with FD undergo ambulatory BP monitoring while keeping a detailed log of their activities (sleep/meal-times/medications/posture/symptoms). Variability in blood pressure overtime will be measured by the standard deviation during awake hours |
| Primary | Highest Systolic Blood Pressure | Day 1 of treatment period | Maximum blood pressure captured on 24-h ambulatory monitoring |
| Primary | Systolic Blood Pressure | up to Week 14 | SBP measured in the seated position |
| Primary | Heart Rate | up to Week 14 | Heart rate in the seated position |
| Primary | Number of Participants Who Displayed Clinical Significant Laboratory Values on CBC or Metabolic Panel | Up to 90 days | Clinically significant laboratory values include complete blood count (CMC) and metabolic panel related to treatment with carbidopa |
| Primary | Number of Participants Who Displayed Clinically Significant Values in Urine Safety Parameters | Up to 90 days | Clinically significant values on urinalysis, urine safety parameters related to treatment with carbidopa |
| Secondary | Severity of Hypotension During an Active Stand Test | up to Week 14 | Lowest blood pressure captured during 3 minutes of standing |
| Secondary | Number of Participants Who Reported Worsening of OH Symptoms or Dropped Out Because of Worsening OH While on Active Study Drug | Up to 90 days | |
| Secondary | Frequency of Worsening Symptoms Noted in the Patient's Diary | Up to 90 Days | A tailored questionnaire to examine symptoms over the treatment period and the used of as needed medications. Each day will have a designated page. Since nausea/vomiting and hypertension occur together in FD we will use a diary consisting of a simplified version of the Rhodes Index 44 symptoms of nausea/retching, with items addressing vomiting/throwing up omitted, as most participants will have had anti-reflux surgery to prevent vomiting (fundoplication), graded on a 5-point scale (appendix 2). The diary will also include space to write down any adverse events on a daily basis. |
| Secondary | 24-h Urinary Norepinephrine Excretion | up to Week 14 | Norepinephrine concentration determined from a 24-hour urine sample in a bottle shielded from light containing preservative. Patients will be instructed to refrigerate their sample and bring it on the morning of their visit in a cool bag. |
| Secondary | Coefficient of Systolic BP Variability (Daytime) | up to Week 14 | The measurement of blood pressure variability based on the standard deviation that also takes into account the underlying level of BP. |
| Secondary | Morning Surge in Systolic BP on Awakening From Sleep (24-h) | up to Week 14 | The morning surge will be calculated as the difference between the mean systolic blood pressure during the hour that included the lowest blood pressure during sleep and maximum value detected within 2-h of awakening from sleep |
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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