Peripheral Dopamine in Postural Tachycardia Syndrome | NCT00685919 | Trialant
NCT00685919
Sponsor
Vanderbilt University
Status
Completed
Last Update Posted
Jan 24, 2022Actual
Enrollment
32Actual
Phase
Phase 2Phase 3
Conditions
Postural Tachycardia Syndrome
Orthostatic Intolerance
Interventions
Carbidopa
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT00685919
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
101499
Secondary IDs
ID
Type
Description
Link
HL071784-05A1
Brief Title
Peripheral Dopamine in Postural Tachycardia Syndrome
Official Title
Kidney Dopamine Effects on Urinary Sodium Excretion in Postural Tachycardia Syndrome
Acronym
Not provided
Organization
Vanderbilt University Medical CenterOTHER
Status Module
Record Verification Date
Jan 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 2008Actual
Primary Completion Date
Jul 2020Actual
Completion Date
Dec 2021Actual
First Submitted Date
May 27, 2008
First Submission Date that Met QC Criteria
May 27, 2008
First Posted Date
May 29, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 6, 2021
Results First Submitted that Met QC Criteria
Aug 23, 2021
Results First Posted Date
Sep 20, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 14, 2022
Last Update Posted Date
Jan 24, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Alfredo Gamboa, Research Associate Professor of Medicine, Vanderbilt UniversityPrincipal Investigator
Lead Sponsor
Vanderbilt UniversityOTHER
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of the proposed research is to determine how changes in kidney dopamine (DA) activity influence urinary sodium excretion. We will decrease DA activity in the kidney by inhibiting DA synthesis via carbidopa administration. We want to compare findings in normal volunteers and in patients with postural tachycardia syndrome (POTS). We will test the null hypothesis (Ho) that the effects of oral carbidopa administration on urinary sodium excretion will not differ between patients with POTS and healthy volunteers.
Detailed Description
We will determine whether inhibition of renal dopamine formation by carbidopa administration leads to a decrease in urinary excretion of dopamine and sodium and whether the response differs in POTS and control populations. Carbidopa effects will be compared to those of a matching placebo, and the sequence of treatments (carbidopa before placebo or placebo before carbidopa) will be randomized.
Each subject will undergo a complete history and physical examination, including an electrocardiogram (EKG).
After achieving sodium balance on a 200 mEq/day sodium diet, subjects will collect urine over 24hr for baseline assessment of sodium and catecholamines.
On this day, the subjects will be admitted to the CRC.
An 18 gauge intravenous catheter will be inserted in order to draw blood.
The subjects will fast from 7 pm until after the next morning's testing.
In the morning, while still supine after the overnight sleep, heart rate and blood pressure will be recorded, and blood will be drawn. The subjects will then stand for 10 minutes. Heart rate and blood pressure will be measured at intervals, and an upright blood sample will be collected.
The subjects will be asked to collect their urine to end the 24hr urine collection. Another 24hr urine collection will be started.
Treatment A (Carbidopa 200mg or placebo) will be given orally following the void, at approximately 7 am. Additional doses will be taken every 6 hours with the last dose at 7 am the following morning.
Subjects will be free to follow their normal routine during the day until returning to the CRC for the night. However, they will need to consume the 200 mEq/day study diet for each meal, collect all urine, and take study medication on schedule
After returning to the CRC, the subjects will fast after 7 pm.
In the morning, supine and standing heart rate and blood pressure will be recorded, and the subjects will be asked to collect their urine to end the 24hr urine collection.
The final dose of study medication (Carbidopa 200mg or placebo) will be given orally following the void, at approximately 7 am.
Supine heart rate and blood pressure will be measured and supine blood samples will be collected hourly for 4 hours after the treatment and at 8 hours after the treatment. Subjects must rest supine for at least 30 minutes before each blood draw.
At 2 hours after treatment, subjects will stand for 10 minutes for upright blood pressure and heart rate measurements and collection of an upright blood sample, as described above. Participants will be asked to rate the severity of common orthostatic symptoms while supine and upright.
Urine will be collected for two 4-hour periods after treatment and from 8 hours to 24 hours after treatment.
Fixed-sodium study diet will be provided after the 4-hour measurements and in the evening.
After at least a 1 day washout period, the study will be repeated with Treatment B
Conditions Module
Conditions
Postural Tachycardia Syndrome
Orthostatic Intolerance
Keywords
Dopamine
Natriuresis
Catecholamines
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
32Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Carbidopa then Placebo
Experimental
Carbidopa 200 mg every 6 hours orally for 5 doses followed by Placebo every 6 hours for 5 doses
Drug: Carbidopa
Drug: Placebo
Placebo then Carbidopa
Experimental
Placebo matching carbidopa given every 6 hours orally for 5 doses followed by Carbidopa
Drug: Carbidopa
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Carbidopa
Drug
200 mg every 6 hours for 5 doses given orally
Carbidopa then Placebo
Placebo then Carbidopa
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
24 Hour Urinary Sodium Excretion During Treatment Normalized to Creatinine
Urine was collected for 24hr during treatment. Urinary volume was measured and the urine was analyzed for sodium and creatinine concentrations. Total amounts of sodium and creatinine excreted over the 24 hr were calculated and results expressed as ratio of sodium:creatinine.
Immediately before the 1st dose of placebo or carbidopa to immediately before the 5th dose (approximately 24 hours)
Secondary Outcomes
Measure
Description
Time Frame
Systolic Blood Pressure Measured at 8 Hours After the Last Dose of Placebo or Carbidopa
Systolic blood pressure was measured once using a Dinamap non-invasive oscillometric blood pressure monitor, 2-4 hours after lunch and after at least 30 minutes of resting supine.
8 hours after the last dose of placebo or carbidopa
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with POTS by the Vanderbilt Autonomic Dysfunction Center based on the following stringent criteria: 1) history of daily orthostatic symptoms for at least 6 months; 2) increase in heart rate (HR) of at least 30 bpm with standing or a standing HR of at least 120 bpm; 3) absence of orthostatic hypotension (defined as a fall in blood pressure (BP)>20/10 mm Hg); and 4) absence of conditions, such as dehydration, substantial weight loss, or systemic illnesses, that could provoke orthostatic intolerance
Upright plasma NE at least 600 pg/mL in patients
Non-smoking
Free of medications with the potential to influence BP
Able and willing to provide informed consent -
Exclusion Criteria:
Overt cause for postural tachycardia (such as acute dehydration)
Significant cardiovascular, pulmonary, hepatic, or hematological disease by history or screening results
Positive urine b-hcg pregnancy test
Evidence of cardiac structural disease (by clinical examination or prior echocardiogram)
Hypertension defined as a BP>145/95 (off medications) or need for antihypertensive medications
Evidence of significant conduction system delay (QRS duration >120 ms) on electrocardiogram
Goldstein DS, Stull R, Eisenhofer G, Gill JR Jr. Urinary excretion of dihydroxyphenylalanine and dopamine during alterations of dietary salt intake in humans. Clin Sci (Lond). 1989 May;76(5):517-22. doi: 10.1042/cs0760517.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Healthy Participants Group: 21 healthy controls enrolled. 3 withdrew prior to randomization. 1 screen failed. 17 healthy participants were randomized. 1 participant was withdrawn due to orthostatic symptoms during baseline testing
Postural Tachycardia Syndrome (POTS) Group: 11 POTS participants were randomized. 1 participant withdrew after the 1st dose of the intervention (placebo).
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Healthy Participants-Placebo Then Carbidopa
Placebo every 6 hours for 5 doses followed by Carbidopa 200 mg every 6 hours orally for 5 doses
FG001
Healthy Participants-Carbidopa Then Placebo
Carbidopa 200 mg every 6 hours for 5 doses followed by Placebo given orally every 6 hours for 5 doses
FG002
Patients With POTS-Placebo Then Carbidopa
Placebo every 6 hours for 5 doses followed by Carbidopa 200 mg every 6 hours orally for 5 doses
FG003
Patients With POTS-Carbidopa Then Placebo
Carbidopa 200 mg every 6 hours for 5 doses followed by Placebo given orally every 6 hours for 5 doses
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0008 subjects8 healthy controls were randomized to receive placebo followed by carbidopa. 1 received only 50 mg doses of carbidopa and her data were excluded.
FG0019 subjects9 healthy controls were randomized to receive carbidopa followed by placebo.
FG0028 subjects8 patients with POTS were randomized to receive placebo followed by carbidopa. 1 of these received only 50 mg doses of carbidopa and her data are excluded.
FG0033 subjects3 patients with POTS were randomized to receive carbidopa followed by placebo.
Baseline A
FG0008 subjectsAfter achieving sodium balance on 200 mEq/day sodium diet, subjects collected baseline 24hr urine. They fasted from 7pm until the next morning. In the morning, while still supine, heart rate and blood pressure were recorded and blood was drawn. Participants then stood for 10 min. Heart rate and blood pressure were measured at intervals and an upright blood sample was collected. Urine was collected to end the 24hr collection.
FG0019 subjectsAfter achieving sodium balance on 200 mEq/day sodium diet, subjects collected baseline 24hr urine. They fasted from 7pm until the next morning. In the morning, while still supine, heart rate and blood pressure were recorded and blood was drawn. Participants then stood for 10 min. Heart rate and blood pressure were measured at intervals and an upright blood sample was collected. Urine was collected to end the 24hr collection. 1 patient withdrew after orthostatic symptoms during baseline.
FG002
Treatment A
FG0007 subjectsFollowing the urine collection to end the baseline urine and the baseline testing, placebo was given orally. Additional doses were given every 6 hours with the last dose at 7am the following morning. Urine was collected over 24hr and supine and upright heart rates, blood pressures and blood samples were collected.
FG0019 subjectsFollowing the urine collection to end the baseline urine and the baseline testing, carbidopa 200 mg was given orally. Additional doses were given every 6 hours with the last dose at 7am the following morning. Urine was collected over 24hr and supine and upright heart rates, blood pressures and blood samples were collected.
FG0028 subjectsFollowing the urine collection to end the baseline urine and the baseline testing, placebo was given orally. Additional doses were given every 6 hours with the last dose at 7am the following morning. Urine was collected over 24hr and supine and upright heart rates, blood pressures and blood samples were collected.
24 hr Post-treatment A
FG0007 subjectsUrine was collected for 24 hr after the last dose of Treatment A.
FG0019 subjectsUrine was collected for 24 hr after the last dose of Treatment A.
FG0027 subjectsUrine was collected for 24 hr after the last dose of Treatment A.
FG003
Baseline B
FG0007 subjectsAfter at least a 1-day washout period, patients underwent baseline procedures as described previously.
FG0019 subjectsAfter at least a 1-day washout period, patients underwent baseline procedures as described previously.
FG0027 subjectsAfter at least a 1-day washout period, patients underwent baseline procedures as described previously.
FG003
Treatment B
FG0007 subjectsFollowing the urine collection to end the baseline urine and the baseline testing, carbidopa 200 mg was given orally. Additional doses were given every 6 hours with the last dose at 7am the following morning. Urine was collected over 24hr and supine and upright heart rates, blood pressures and blood samples were collected.
FG0019 subjectsFollowing the urine collection to end the baseline urine and the baseline testing, placebo was given orally. Additional doses were given every 6 hours with the last dose at 7am the following morning. Urine was collected over 24hr and supine and upright heart rates, blood pressures and blood samples were collected.
FG0027 subjectsFollowing the urine collection to end the baseline urine and the baseline testing, carbidopa 200 mg was given orally. Additional doses were given every 6 hours with the last dose at 7am the following morning. Urine was collected over 24hr and supine and upright heart rates, blood pressures and blood samples were collected.
24 hr Post Treatment B
FG0007 subjectsUrine was collected for 24 hr after last dose of Treatment B.
FG0019 subjectsUrine was collected for 24 hr after last dose of Treatment B.
FG0027 subjectsUrine was collected for 24 hr after last dose of Treatment B.
FG003
COMPLETED
FG0007 subjects
FG0019 subjects
FG0027 subjects
FG0033 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Healthy Participant Group: Data is excluded for 1 participant who was withdrawn due to orthostatic symptoms during baseline testing.
Postural Tachycardia Syndrome (POTS) Group: Data is excluded for 1 participant who was withdrawn after the 1st dose of the intervention (placebo).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Healthy Participants-Placebo Then Carbidopa
Placebo every 6 hours for 5 doses followed by Carbidopa 200 mg every 6 hours orally for 5 doses
BG001
Healthy Participants-Carbidopa Then Placebo
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
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
24 Hour Urinary Sodium Excretion During Treatment Normalized to Creatinine
Urine was collected for 24hr during treatment. Urinary volume was measured and the urine was analyzed for sodium and creatinine concentrations. Total amounts of sodium and creatinine excreted over the 24 hr were calculated and results expressed as ratio of sodium:creatinine.
No data analysis for the following:
Healthy Placebo Group:
1 subject with discarded urine sample
1 subject who received only 50mg carbidopa (data for all arms excluded)
Healthy Carbidopa Group:
1 subject who received only 50mg carbidopa (wrong dose)
POTS Placebo Group:
1 subject with discarded urine sample
1 subject who received only 50mg carbidopa (data for all arms excluded)
POTS Carbidopa Group:
1 subject who received only 50mg carbidopa (wrong dose)
Posted
Mean
Standard Deviation
Milliequivalents per gram (mEq/g)
Immediately before the 1st dose of placebo or carbidopa to immediately before the 5th dose (approximately 24 hours)
ID
Title
Description
OG000
Adverse Events Module
Frequency Threshold
0
Time Frame
Participants were followed for 24 hours after the 5th dose of treatment.
Description
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Events were self-reported by participants.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Healthy Participants-Placebo
Placebo matching carbidopa given every 6 hours orally for 5 doses
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Head rush
Nervous system disorders
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
Yes
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Alfredo Gamboa, MD
Vanderbilt University Medical Center
615-875-1003
alfredo.gamboa@vumc.org
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP_ICF
Yes
Yes
Yes
Study Protocol, Statistical Analysis Plan, and Informed Consent Form
every 6 hours for 5 doses, given orally, and matching Carbidopa
Carbidopa then Placebo
Placebo then Carbidopa
Plasma Catecholamines (Norepinephrine) After the Last Dose of Placebo or Carbidopa
Blood samples were collected while resting supine for at least 30 minutes and 2 to 4 hours after lunch. For catecholamine measurements, blood was collected in chilled vacuum tubes with EDTA. Plasma was separated and stored with added reduced glutathione (Amersham International PLC) at -70°C until the assay. Plasma catecholamines were measured by a method that involves batch alumina extraction followed by high-performance liquid chromatography (HPLC) for separation with electrochemical detection and quantification.
8 hours after the last dose of placebo or carbidopa
Plasma Catecholamines (DOPA) After the Last Dose of Placebo or Carbidopa
Blood samples were collected while resting supine for at least 30 minutes and 2 to 4 hours after lunch. For catecholamine measurements, blood was collected in chilled vacuum tubes with EDTA. Plasma was separated and stored with added reduced glutathione (Amersham International PLC) at -70°C until the assay. Plasma catecholamines were measured by a method that involves batch alumina extraction followed by high-performance liquid chromatography (HPLC) for separation with electrochemical detection and quantification.
8 hours after the last dose of placebo or carbidopa
24 Hour Urinary Catecholamine (DOPA) Excretion During Treatment Normalized to Creatinine
Urine was collected over 24 hours during treatment. The urinary volume was measured and the urine was analyzed for creatinine and catecholamines. Total amounts of creatinine and catecholamines were calculated and the results are expressed as catecholamine:creatinine.
Immediately before the 1st dose of Placebo or Carbidopa and ending immediately before the last dose (approximately 24 hours)
24 Hour Urinary Catecholamine (Dopamine) Excretion During Treatment Normalized to Creatinine
Urine was collected over 24 hours during treatment. The urinary volume was measured and the urine was analyzed for creatinine and catecholamines. Total amounts of creatinine and catecholamines were calculated and the results are expressed as catecholamine:creatinine.
Immediately before the 1st dose of Placebo or Carbidopa and ending immediately before the last dose (approximately 24 hours)
Supine Plasma Renin Activity 2 Hours After the Last Dose of Placebo or Carbidopa
Blood samples were collected while resting supine for at least 30 minutes and 1 1/2 to 2 hours after breakfast. Samples were processed and sent to the Vanderbilt Clinic Laboratory for assay.
2 hours after the last dose of placebo or carbidopa
Plasma Sodium After the Last Dose of Placebo or Carbidopa
Blood samples were collected while resting supine for at least 30 minutes and 2 to 4 hours after lunch. Samples were processed and sent to the Vanderbilt Clinical Laboratory for assay.
8 hours after the last dose of placebo or carbidopa
Kuchel O, Buu NT, Unger T. Dopamine-sodium relationship: is dopamine a part of the endogenous natriuretic system? Contrib Nephrol. 1978;13:27-36. doi: 10.1159/000402132.
Stokes GS, Monaghan JC, Pillai DN. Effects of carbidopa and of intravenous saline infusion into normal and hypertensive subjects on urinary free and conjugated dopamine. J Hypertens. 1997 Jul;15(7):761-8. doi: 10.1097/00004872-199715070-00008.
Jacob G, Robertson D, Mosqueda-Garcia R, Ertl AC, Robertson RM, Biaggioni I; New Collective Author. Hypovolemia in syncope and orthostatic intolerance role of the renin-angiotensin system. Am J Med. 1997 Aug;103(2):128-33. doi: 10.1016/s0002-9343(97)00133-2.
8 subjects
After achieving sodium balance on 200 mEq/day sodium diet, subjects collected baseline 24hr urine. They fasted from 7pm until the next morning. In the morning, while still supine, heart rate and blood pressure were recorded and blood was drawn. Participants then stood for 10 min. Heart rate and blood pressure were measured at intervals and an upright blood sample was collected. Urine was collected to end the 24hr collection. 1 patient withdrew after orthostatic symptoms during baseline.
FG0033 subjectsAfter achieving sodium balance on 200 mEq/day sodium diet, subjects collected baseline 24hr urine. They fasted from 7pm until the next morning. In the morning, while still supine, heart rate and blood pressure were recorded and blood was drawn. Participants then stood for 10 min. Heart rate and blood pressure were measured at intervals and an upright blood sample was collected. Urine was collected to end the 24hr collection.
FG0033 subjectsFollowing the urine collection to end the baseline urine and the baseline testing, carbidopa 200 mg was given orally. Additional doses were given every 6 hours with the last dose at 7am the following morning. Urine was collected over 24hr and supine and upright heart rates, blood pressures and blood samples were collected.
3 subjects
Urine was collected for 24 hr after the last dose of Treatment A.
3 subjects
After at least a 1-day washout period, patients underwent baseline procedures as described previously.
FG0033 subjectsFollowing the urine collection to end the baseline urine and the baseline testing, placebo was given orally. Additional doses were given every 6 hours with the last dose at 7am the following morning. Urine was collected over 24hr and supine and upright heart rates, blood pressures and blood samples were collected.
3 subjects
Urine was collected for 24 hr after last dose of Treatment B.
0 subjects
Physician Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Carbidopa 200 mg every 6 hours for 5 doses followed by Placebo given orally every 6 hours for 5 doses
BG002
Patients With POTS-Placebo Then Carbidopa
Placebo every 6 hours for 5 doses followed by Carbidopa 200 mg every 6 hours orally for 5 doses
BG003
POTS-Carbidopa Then Placebo
Carbidopa 200 mg every 6 hours for 5 doses followed by Placebo given orally every 6 hours for 5 doses
BG004
Total
Total of all reporting groups
8
BG0018
BG0027
BG0033
BG00426
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00034± 11
BG00132± 10
BG00231± 10
BG00337± 3
BG00432.8± 9.5
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0008
BG0017
BG0027
BG0033
BG00425
Male
BG0000
BG0011
BG0020
BG0030
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG0020
BG0030
BG0040
Not Hispanic or Latino
BG0008
BG0018
BG0027
BG0033
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
Asian
BG0000
BG0010
BG0020
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0000
BG0011
BG0020
BG0030
BG004
White
BG0008
BG0017
BG0027
BG0033
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG0008
BG0018
BG0027
BG0033
BG00426
Healthy Participants Who Received Placebo as Treatment A or Treatment B
Healthy participants received Placebo matching Carbidopa given every 6 hours orally for 5 doses
OG001
Healthy Participants Who Received Carbidopa as Treatment A or Treatment B
Healthy participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
OG002
Postural Tachycardia Syndrome (POTS) Participants Who Received Placebo as Treatment A or Treatment B
POTS participants received Placebo matching carbidopa given every 6 hours orally for 5 doses
OG003
Postural Tachycardia Syndrome (POTS) Patients Who Received Carbidopa as Treatment A or Treatment B
POTS participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
Units
Counts
Participants
OG00014
OG00115
OG0028
OG0039
Title
Denominators
Categories
Title
Measurements
OG000140± 29
OG001132± 38
OG002137± 30
OG003154± 31
Secondary
Systolic Blood Pressure Measured at 8 Hours After the Last Dose of Placebo or Carbidopa
Systolic blood pressure was measured once using a Dinamap non-invasive oscillometric blood pressure monitor, 2-4 hours after lunch and after at least 30 minutes of resting supine.
No data analysis for the following:
Healthy Placebo Group:
1 subject with missing systolic blood pressure 8-hours after the last dose of Placebo
1 subject who received only 50mg carbidopa (data for all arms excluded)
Healthy Carbidopa Group:
1 subject who received only 50mg carbidopa (wrong dose)
POTS Placebo Group:
1 subject who received only 50mg carbidopa (data for all arms excluded)
POTS Carbidopa Group:
1 subject who received only 50mg carbidopa (wrong dose)
Posted
Mean
Standard Deviation
millimeters of mercury (mmHg)
8 hours after the last dose of placebo or carbidopa
ID
Title
Description
OG000
Healthy Participants Who Received Placebo as Treatment A or Treatment B
Healthy participants received Placebo matching Carbidopa given every 6 hours orally for 5 doses
OG001
Healthy Participants Who Received Carbidopa as Treatment A or Treatment B
Healthy participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
OG002
Postural Tachycardia Syndrome (POTS) Participants Who Received Placebo as Treatment A or Treatment B
POTS participants received Placebo matching carbidopa given every 6 hours orally for 5 doses
OG003
Postural Tachycardia Syndrome (POTS) Patients Who Received Carbidopa as Treatment A or Treatment B
POTS participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
Units
Counts
Participants
OG00014
OG00115
OG0029
OG003
Title
Denominators
Categories
Title
Measurements
OG000103± 4
OG001101± 8
OG002102± 9
OG003
Secondary
Plasma Catecholamines (Norepinephrine) After the Last Dose of Placebo or Carbidopa
Blood samples were collected while resting supine for at least 30 minutes and 2 to 4 hours after lunch. For catecholamine measurements, blood was collected in chilled vacuum tubes with EDTA. Plasma was separated and stored with added reduced glutathione (Amersham International PLC) at -70°C until the assay. Plasma catecholamines were measured by a method that involves batch alumina extraction followed by high-performance liquid chromatography (HPLC) for separation with electrochemical detection and quantification.
No data analysis for the following:
Healthy Placebo Group:
1 subject who received only 50mg carbidopa (data for all arms excluded)
Healthy Carbidopa Group:
1 subject who received only 50mg carbidopa (wrong dose)
POTS Placebo Group:
1 subject who received only 50mg carbidopa (data for all arms excluded)
POTS Carbidopa Group:
1 subject who received only 50mg carbidopa (wrong dose)
Posted
Mean
Standard Deviation
Picograms per milliliter (pg/mL)
8 hours after the last dose of placebo or carbidopa
ID
Title
Description
OG000
Healthy Participants Who Received Placebo as Treatment A or Treatment B
Healthy participants received Placebo matching Carbidopa given every 6 hours orally for 5 doses
OG001
Healthy Participants Who Received Carbidopa as Treatment A or Treatment B
Healthy participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
OG002
Postural Tachycardia Syndrome (POTS) Participants Who Received Placebo as Treatment A or Treatment B
POTS participants received Placebo matching carbidopa given every 6 hours orally for 5 doses
OG003
Postural Tachycardia Syndrome (POTS) Patients Who Received Carbidopa as Treatment A or Treatment B
POTS participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
Units
Counts
Participants
OG00015
OG00115
OG0029
OG003
Title
Denominators
Categories
Title
Measurements
OG000150± 46
OG001181± 100
OG002278± 84
OG003
Secondary
Plasma Catecholamines (DOPA) After the Last Dose of Placebo or Carbidopa
Blood samples were collected while resting supine for at least 30 minutes and 2 to 4 hours after lunch. For catecholamine measurements, blood was collected in chilled vacuum tubes with EDTA. Plasma was separated and stored with added reduced glutathione (Amersham International PLC) at -70°C until the assay. Plasma catecholamines were measured by a method that involves batch alumina extraction followed by high-performance liquid chromatography (HPLC) for separation with electrochemical detection and quantification.
No data analysis for the following:
Healthy Placebo Group:
1 subject who received only 50mg carbidopa (data for all arms excluded)
Healthy Carbidopa Group:
1 subject who received only 50mg carbidopa (wrong dose)
POTS Placebo Group:
1 subject who received only 50mg carbidopa (data for all arms excluded)
POTS Carbidopa Group:
1 subject who received only 50mg carbidopa (wrong dose)
Posted
Mean
Standard Deviation
Picograms per milliliter (pg/mL)
8 hours after the last dose of placebo or carbidopa
ID
Title
Description
OG000
Healthy Participants Who Received Placebo as Treatment A or Treatment B
Healthy participants received Placebo matching Carbidopa given every 6 hours orally for 5 doses
OG001
Healthy Participants Who Received Carbidopa as Treatment A or Treatment B
Healthy participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
OG002
Postural Tachycardia Syndrome (POTS) Participants Who Received Placebo as Treatment A or Treatment B
POTS participants received Placebo matching carbidopa given every 6 hours orally for 5 doses
OG003
Postural Tachycardia Syndrome (POTS) Patients Who Received Carbidopa as Treatment A or Treatment B
POTS participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
Units
Counts
Participants
OG00015
OG00115
OG0029
OG003
Title
Denominators
Categories
Title
Measurements
OG0001813± 463
OG00120297± 9509
OG0022104± 700
OG003
Secondary
24 Hour Urinary Catecholamine (DOPA) Excretion During Treatment Normalized to Creatinine
Urine was collected over 24 hours during treatment. The urinary volume was measured and the urine was analyzed for creatinine and catecholamines. Total amounts of creatinine and catecholamines were calculated and the results are expressed as catecholamine:creatinine.
No data analysis for the following participants:
Healthy Placebo:
1 w/ discarded urine sample
1 w/ urine not analyzed for catecholamines
1 received only 50mg carbidopa (data for all arms excluded)
Healthy Carbidopa:
1 w/ urine not analyzed for catecholamines
1 received only 50mg carbidopa (wrong dose)
POTS Placebo:
1 w/ discarded urine sample
1 received only 50mg carbidopa (data for all arms excluded)
POTS Carbidopa:
1 received only 50mg carbidopa (wrong dose)
Posted
Mean
Standard Deviation
Micrograms per milligrams (ug/mg)
Immediately before the 1st dose of Placebo or Carbidopa and ending immediately before the last dose (approximately 24 hours)
ID
Title
Description
OG000
Healthy Participants Who Received Placebo as Treatment A or Treatment B
Healthy participants received Placebo matching Carbidopa given every 6 hours orally for 5 doses
OG001
Healthy Participants Who Received Carbidopa as Treatment A or Treatment B
Healthy participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
OG002
Postural Tachycardia Syndrome (POTS) Participants Who Received Placebo as Treatment A or Treatment B
POTS participants received Placebo matching carbidopa given every 6 hours orally for 5 doses
OG003
Postural Tachycardia Syndrome (POTS) Patients Who Received Carbidopa as Treatment A or Treatment B
POTS participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
Units
Counts
Participants
OG00013
OG00114
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.024± 0.014
OG0010.283± 0.194
OG0020.026± 0.015
OG003
Secondary
24 Hour Urinary Catecholamine (Dopamine) Excretion During Treatment Normalized to Creatinine
Urine was collected over 24 hours during treatment. The urinary volume was measured and the urine was analyzed for creatinine and catecholamines. Total amounts of creatinine and catecholamines were calculated and the results are expressed as catecholamine:creatinine.
No data analysis for the following participants:
Healthy Placebo:
1 w/ discarded urine sample
1 w/ urine not analyzed for catecholamines
1 received only 50mg carbidopa (data for all arms excluded)
Healthy Carbidopa:
1 w/ urine not analyzed for catecholamines
1 received only 50mg carbidopa (wrong dose)
POTS Placebo:
1 w/ discarded urine sample
1 received only 50mg carbidopa (data for all arms excluded)
POTS Carbidopa:
1 received only 50mg carbidopa (wrong dose)
Posted
Mean
Standard Deviation
Micrograms per milligrams (ug/mg)
Immediately before the 1st dose of Placebo or Carbidopa and ending immediately before the last dose (approximately 24 hours)
ID
Title
Description
OG000
Healthy Participants Who Received Placebo as Treatment A or Treatment B
Healthy participants received Placebo matching Carbidopa given every 6 hours orally for 5 doses
OG001
Healthy Participants Who Received Carbidopa as Treatment A or Treatment B
Healthy participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
OG002
Postural Tachycardia Syndrome (POTS) Participants Who Received Placebo as Treatment A or Treatment B
POTS participants received Placebo matching carbidopa given every 6 hours orally for 5 doses
OG003
Postural Tachycardia Syndrome (POTS) Patients Who Received Carbidopa as Treatment A or Treatment B
POTS participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
Units
Counts
Participants
OG00013
OG00114
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.208± 0.061
OG0010.035± 0.015
OG0020.24± 0.081
OG003
Secondary
Supine Plasma Renin Activity 2 Hours After the Last Dose of Placebo or Carbidopa
Blood samples were collected while resting supine for at least 30 minutes and 1 1/2 to 2 hours after breakfast. Samples were processed and sent to the Vanderbilt Clinic Laboratory for assay.
No data analysis for the following:
Healthy Placebo Group:
1 subject who received only 50mg carbidopa (data for all arms excluded)
Healthy Carbidopa Group:
1 subject who received only 50mg carbidopa (wrong dose)
POTS Placebo Group:
1 subject who received only 50mg carbidopa (data for all arms excluded)
POTS Carbidopa Group:
1 subject who received only 50mg carbidopa (wrong dose)
Posted
Mean
Standard Deviation
Nanograms per milliliter per hour (ng/mL
2 hours after the last dose of placebo or carbidopa
ID
Title
Description
OG000
Healthy Participants Who Received Placebo as Treatment A or Treatment B
Healthy participants received Placebo matching Carbidopa given every 6 hours orally for 5 doses
OG001
Healthy Participants Who Received Carbidopa as Treatment A or Treatment B
Healthy participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
OG002
Postural Tachycardia Syndrome (POTS) Participants Who Received Placebo as Treatment A or Treatment B
POTS participants received Placebo matching carbidopa given every 6 hours orally for 5 doses
OG003
Postural Tachycardia Syndrome (POTS) Patients Who Received Carbidopa as Treatment A or Treatment B
POTS participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
Units
Counts
Participants
OG00015
OG00115
OG0029
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.153± 0.926
OG0011.033± 0.529
OG0021.544± 1.02
OG003
Secondary
Plasma Sodium After the Last Dose of Placebo or Carbidopa
Blood samples were collected while resting supine for at least 30 minutes and 2 to 4 hours after lunch. Samples were processed and sent to the Vanderbilt Clinical Laboratory for assay.
No data analysis for the following:
Healthy Placebo Group:
1 subject who received only 50mg carbidopa (data for all arms excluded)
Healthy Carbidopa Group:
1 subject who received only 50mg carbidopa (wrong dose)
POTS Placebo Group:
1 subject who received only 50mg carbidopa (data for all arms excluded)
POTS Carbidopa Group:
1 subject who received only 50mg carbidopa (wrong dose)
Posted
Mean
Standard Deviation
Milliequivalents per liter (mEq/L)
8 hours after the last dose of placebo or carbidopa
ID
Title
Description
OG000
Healthy Participants Who Received Placebo as Treatment A or Treatment B
Healthy participants received Placebo matching Carbidopa given every 6 hours orally for 5 doses
OG001
Healthy Participants Who Received Carbidopa as Treatment A or Treatment B
Healthy participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
OG002
Postural Tachycardia Syndrome (POTS) Participants Who Received Placebo as Treatment A or Treatment B
POTS participants received Placebo matching carbidopa given every 6 hours orally for 5 doses
OG003
Postural Tachycardia Syndrome (POTS) Patients Who Received Carbidopa as Treatment A or Treatment B
POTS participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
Units
Counts
Participants
OG00015
OG00115
OG0029
OG003
Title
Denominators
Categories
Title
Measurements
OG000138± 1.9
OG001138± 1.9
OG002139± 2.2
OG003
0
17
0
17
1
17
EG001
Healthy Participants-Carbidopa
Carbidopa 200 mg every 6 hours orally for 5 doses
0
17
0
17
1
17
EG002
POTS Participants-Placebo
Placebo matching carbidopa given every 6 hours orally for 5 doses