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Trial record 4 of 8 for:    "Orthostatic Intolerance" | "Bromides"

Treatment and Prognosis of Neurogenic Orthostatic Hypotension : A Prospective Randomized Study

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ClinicalTrials.gov Identifier: NCT02308124
Recruitment Status : Completed
First Posted : December 4, 2014
Results First Posted : April 17, 2017
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
Kon Chu, Seoul National University Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Orthostatic; Hypotension, Neurogenic
Interventions Drug: Midodrine
Drug: Pyridostigmine Bromide
Drug: Midodrine + pyridostigmine
Enrollment 87
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Midodrine Only Pyridostigmine Only Midodrine + Pyridostigmine
Hide Arm/Group Description Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary. Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary. Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
Period Title: Overall Study
Started 29 29 29
Completed 23 21 21
Not Completed 6 8 8
Reason Not Completed
Lost to Follow-up             6             6             6
Adverse Event             0             2             2
Arm/Group Title Midodrine Only Pyridostigmine Only Midodrine + Pyridostigmine Total
Hide Arm/Group Description Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary. Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary. Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary. Total of all reporting groups
Overall Number of Baseline Participants 29 29 29 87
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 29 participants 29 participants 87 participants
59.2  (17.7) 59.7  (13.4) 52.7  (16.2) 57.2  (16.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 29 participants 29 participants 87 participants
Female
14
  48.3%
17
  58.6%
15
  51.7%
46
  52.9%
Male
15
  51.7%
12
  41.4%
14
  48.3%
41
  47.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 29 participants 29 participants 29 participants 87 participants
29 29 29 87
Supine systolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 29 participants 29 participants 29 participants 87 participants
137.3  (20.9) 124.5  (18.5) 122.0  (15.6) 127.9  (19.4)
Supine diastolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 29 participants 29 participants 29 participants 87 participants
83.2  (12.8) 76.5  (9.8) 76.9  (10.4) 78.9  (11.4)
Supine heart rate  
Mean (Standard Deviation)
Unit of measure:  Beats per Minute
Number Analyzed 29 participants 29 participants 29 participants 87 participants
68.0  (11.3) 66.7  (13.5) 67.0  (10.7) 67.2  (11.8)
Orthostatic systolic blood pressure change   [1] 
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 29 participants 29 participants 29 participants 87 participants
-24.7  (9.9) -23.3  (12.5) -22.5  (10.1) -23.5  (10.8)
[1]
Measure Description: Maximum decrements in SBP within 3 minutes of standing were recorded.
Orthostatic diastolic blood pressure change   [1] 
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 29 participants 29 participants 29 participants 87 participants
-13.4  (9.0) -15.5  (9.9) -13.4  (8.2) -14.1  (9.0)
[1]
Measure Description: Maximum decrements in DBP within 3 minutes of standing were recorded.
1.Primary Outcome
Title Change in Orthostatic BP Drop
Hide Description Change of orthostatic SBP and DBP drop after 3-month medical treatment compared to initial results.
Time Frame after 3-month medical treatment
Hide Outcome Measure Data
Hide Analysis Population Description
At 3 months after treatment, 65 patients were evaluated (Midodrine only; 23, Pyridostigmine only; 21, Midodrine + Pyridostigmine; 21). 22 additional patients missed visit (Midodrine only; 6, Pyridostigmine only; 8, Midodrine + Pyridostigmine; 8)
Arm/Group Title Midodrine Only Pyridostigmine Only Midodrine + Pyridostigmine
Hide Arm/Group Description:
Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
Overall Number of Participants Analyzed 23 21 21
Mean (Standard Deviation)
Unit of Measure: mmHg
Changes in SBP drop 11.1  (16.9) 13.6  (20.1) 8.9  (9.9)
Changes in DBP drop 7.5  (15.3) 11.1  (17.7) 7.4  (14.2)
2.Secondary Outcome
Title Change of the Orthostatic Hypotension Associated Symptom Questionnaire (OH Questionnaire (OHQ)).
Hide Description

Change of the OH associated symptom survey result after 3-month medical treatment compared to initial results.

OHQ questionnaire has two components: the OH daily activity scale (OHDAS), which contains 4 items measuring the impact of OH on daily activities, and the OH symptom assessment (OHSA), which contains 6 items measuring the symptoms of OH (dizziness/light headedness, vision disturbance, weakness, fatigue, trouble concentrating, and head/neck discomfort).This questionnaire reflects the severity of OH-related symptoms on a 10-point scale, with 0 indicating the absence of a symptom and 10 indicating maximal severity.

** OHQ total score minimal 0 ~ maximal 100

Time Frame after 3-month medical treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
At 3 months after treatment, 65 patients were evaluated (Midodrine only; 23, Pyridostigmine only; 21, Midodrine + Pyridostigmine; 21). 22 additional patients missed visit (Midodrine only; 6, Pyridostigmine only; 8, Midodrine + Pyridostigmine; 8)
Arm/Group Title Midodrine Only Pyridostigmine Only Midodrine + Pyridostigmine
Hide Arm/Group Description:
Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
Overall Number of Participants Analyzed 23 21 21
Mean (Standard Deviation)
Unit of Measure: points
-16.2  (15.5) -17.2  (20.3) -12.6  (14.8)
3.Secondary Outcome
Title Change of the Depression Score (Beck Depression Inventory-II )
Hide Description

Change of the depression score after 3-month medical treatment compared to initial results.

21 multiple-choice questions, each of which can be scored from 0 to 3. Higher score represent higher degree of depression.

Score Normal; 0-13, Mild depression; 14-19, Moderate depression; 20-28, Severe depression; 29-63

Time Frame after 3-month medical treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
At 3 months after treatment, 65 patients were evaluated (Midodrine only; 23, Pyridostigmine only; 21, Midodrine + Pyridostigmine; 21). 22 additional patients missed visit (Midodrine only; 6, Pyridostigmine only; 8, Midodrine + Pyridostigmine; 8)
Arm/Group Title Midodrine Only Pyridostigmine Only Midodrine + Pyridostigmine
Hide Arm/Group Description:
Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
Overall Number of Participants Analyzed 23 21 21
Mean (Standard Deviation)
Unit of Measure: points
-6.8  (5.6) -7.8  (6.5) -3.5  (8.0)
4.Secondary Outcome
Title Changes in Health-related Quality of Life
Hide Description

changes in Short Form (36) Health Survey version 2 (SF-36v2) physical component summary scale (PCS) compared to the baseline

SF-36v2 measures eight HRQOL domains (physical functioning, role limitation caused by physical problems, bodily pain, general health, vitality, social functioning, role limitation caused by emotional problems, and mental health) summarized into two summary scales that are normalized to the population (mean=50, standard deviation=10): the physical component summary scale (PCS) and the mental component summary scale (MCS).20 Better HRQOL is reflected by higher SF-36v2 scores.

Time Frame changes at 3 months after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
At 3 months after treatment, 65 patients were evaluated (Midodrine only; 23, Pyridostigmine only; 21, Midodrine + Pyridostigmine; 21). 22 additional patients missed visit (Midodrine only; 6, Pyridostigmine only; 8, Midodrine + Pyridostigmine; 8)
Arm/Group Title Midodrine Only Pyridostigmine Only Midodrine + Pyridostigmine
Hide Arm/Group Description:
Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
Overall Number of Participants Analyzed 23 21 21
Mean (Standard Deviation)
Unit of Measure: points
5.6  (6.8) 4.2  (9.1) 2.7  (7.0)
5.Secondary Outcome
Title Changes in Health-related Quality of Life
Hide Description

changes in Short Form (36) Health Survey version 2 (SF-36v2) mental component summary scale (MCS)

SF-36v2 measures eight HRQOL domains (physical functioning, role limitation caused by physical problems, bodily pain, general health, vitality, social functioning, role limitation caused by emotional problems, and mental health) summarized into two summary scales that are normalized to the population (mean=50, standard deviation=10): the physical component summary scale (PCS) and the mental component summary scale (MCS).20 Better HRQOL is reflected by higher SF-36v2 scores.

Time Frame changes at 3 months after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
At 3 months after treatment, 65 patients were evaluated (Midodrine only; 23, Pyridostigmine only; 21, Midodrine + Pyridostigmine; 21). 22 additional patients missed visit (Midodrine only; 6, Pyridostigmine only; 8, Midodrine + Pyridostigmine; 8)
Arm/Group Title Midodrine Only Pyridostigmine Only Midodrine + Pyridostigmine
Hide Arm/Group Description:
Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
Overall Number of Participants Analyzed 23 21 21
Mean (Standard Deviation)
Unit of Measure: points
5.0  (8.6) 6.7  (8.9) 0.4  (11.2)
Time Frame Possible side effects were checked by direct questioning at each visit at 1 and 3 months after treatment. Expected adverse reactions were listed in the protocol.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Midodrine Only Pyridostigmine Only Midodrine + Pyridostigmine
Hide Arm/Group Description Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary. Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary. Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
All-Cause Mortality
Midodrine Only Pyridostigmine Only Midodrine + Pyridostigmine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Midodrine Only Pyridostigmine Only Midodrine + Pyridostigmine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/29 (0.00%)      0/29 (0.00%)      0/29 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Midodrine Only Pyridostigmine Only Midodrine + Pyridostigmine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/29 (3.45%)      6/29 (20.69%)      3/29 (10.34%)    
Gastrointestinal disorders       
nausea   0/29 (0.00%)  0 2/29 (6.90%)  2 2/29 (6.90%)  2
Nervous system disorders       
Headache   1/29 (3.45%)  1 2/29 (6.90%)  2 0/29 (0.00%)  0
dizziness   1/29 (3.45%)  1 5/29 (17.24%)  5 1/29 (3.45%)  1
tremor   0/29 (0.00%)  0 1/29 (3.45%)  1 0/29 (0.00%)  0
Indicates events were collected by systematic assessment
This study lacked a placebo group and a blinding process Compared with previous studies, which focused on primary autonomic degenerative disorders, our study included more patients with peripheral autonomic neuropathy.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jung-Ick Byun
Organization: SNUH
Phone: +8224406254
Publications:
Smith ND. Orthostatic Hypotension in the Patient with Diabetes: A Broad Review of Pharmacologic Treatment Options. Journal of Pharmacy Technology. 2013 January 1, 2013;29(1):23-34.
Responsible Party: Kon Chu, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02308124     History of Changes
Other Study ID Numbers: 1409066609
First Submitted: December 2, 2014
First Posted: December 4, 2014
Results First Submitted: January 4, 2017
Results First Posted: April 17, 2017
Last Update Posted: April 17, 2017