Trial Outcomes & Findings for Efficacy and Safety of Coumarin and Troxerutin in the Symptomatic Treatment of Chronic Venous Insufficiency (NCT NCT01848210)
NCT ID: NCT01848210
Last Updated: 2016-11-11
Results Overview
Change in the partial volume of legs will be measured using a water plethysmometer. The volume of water (at 34 ± 0.2 °C) displaced after limb immersion is collected in an empty plastic Beaker which has been previously weighed (scale tare). The equilibrium/stability will be estimated using the absolute difference between measures of volume obtained at the Week 16 visit and Baseline to determine the reduction in edema.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
829 participants
Primary outcome timeframe
Baseline and Week 16
Results posted on
2016-11-11
Participant Flow
Participants took part in the study at 8 investigative sites in Brazil from 28 May 2013 to 29 September 2015.
Participants with a diagnosis of chronic venous insufficiency were enrolled equally in 1 of 2 treatment groups, three times a day coumarin 30 mg and troxerutin 180 mg fixed-dose combination tablets or matching placebo.
Participant milestones
| Measure |
Coumarin + Troxerutin
Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
|
Placebo
Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
411
|
418
|
|
Overall Study
Safety Population-Received Study Drug
|
394
|
398
|
|
Overall Study
Intent-to-Treat (ITT) Population
|
383
|
388
|
|
Overall Study
Per Protocol Population
|
222
|
245
|
|
Overall Study
COMPLETED
|
323
|
340
|
|
Overall Study
NOT COMPLETED
|
88
|
78
|
Reasons for withdrawal
| Measure |
Coumarin + Troxerutin
Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
|
Placebo
Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
|
|---|---|---|
|
Overall Study
Informed Consent Form Withdrawal
|
28
|
24
|
|
Overall Study
Lost to Follow-up
|
24
|
12
|
|
Overall Study
Protocol Violation
|
3
|
5
|
|
Overall Study
Use of Forbidden Drugs
|
9
|
10
|
|
Overall Study
Impedition Condition
|
5
|
9
|
|
Overall Study
Adverse Event
|
7
|
9
|
|
Overall Study
Discontinuation Criterion
|
5
|
7
|
|
Overall Study
Hypesensitivity
|
1
|
0
|
|
Overall Study
Hepatic Function Alteration
|
4
|
0
|
|
Overall Study
Chronic Venous Insufficiency Course
|
1
|
2
|
|
Overall Study
Administrative
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of Coumarin and Troxerutin in the Symptomatic Treatment of Chronic Venous Insufficiency
Baseline characteristics by cohort
| Measure |
Coumarin + Troxerutin
n=383 Participants
Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
|
Placebo
n=388 Participants
Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
|
Total
n=771 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.95 years
n=5 Participants
|
55.81 years
n=7 Participants
|
55.88 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
337 Participants
n=5 Participants
|
351 Participants
n=7 Participants
|
688 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
221 participants
n=5 Participants
|
240 participants
n=7 Participants
|
461 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
48 participants
n=5 Participants
|
55 participants
n=7 Participants
|
103 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Brown
|
110 participants
n=5 Participants
|
86 participants
n=7 Participants
|
196 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
383 participants
n=5 Participants
|
388 participants
n=7 Participants
|
771 participants
n=5 Participants
|
|
Height
|
1.58 meters
n=5 Participants
|
1.59 meters
n=7 Participants
|
1.59 meters
n=5 Participants
|
|
Weight
|
74.40 kg
n=5 Participants
|
73.38 kg
n=7 Participants
|
73.89 kg
n=5 Participants
|
|
Body Mass Index (BMI)
|
29.76 kg/cm^2
n=5 Participants
|
29.14 kg/cm^2
n=7 Participants
|
29.45 kg/cm^2
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 16Population: Participants from the ITT population, all eligible participants who received study drug and had at least one efficacy assessment at Visit 1 (28 ± 5 days after start of treatment), with data available for analysis.
Change in the partial volume of legs will be measured using a water plethysmometer. The volume of water (at 34 ± 0.2 °C) displaced after limb immersion is collected in an empty plastic Beaker which has been previously weighed (scale tare). The equilibrium/stability will be estimated using the absolute difference between measures of volume obtained at the Week 16 visit and Baseline to determine the reduction in edema.
Outcome measures
| Measure |
Coumarin + Troxerutin
n=333 Participants
Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
|
Placebo
n=347 Participants
Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
|
|---|---|---|
|
Mean Change (Reduction) From Baseline in Volume of Reference Leg at Week 16
|
1.13 milliliters (mL)
Standard Deviation 93.67
|
5.78 milliliters (mL)
Standard Deviation 107.26
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: ITT population, all participants who received study drug and had at least one efficacy assessment at Visit 1 (28 ± 5 days after start of treatment). Last observation carried forward (LOCF).
Local Complaint Severity will be assessed using the Severity Score of Local Complaints that comprises 8 items: 1=tired legs, 2=heavy legs, 3= feeling of tension, 4=feeling of swelling, 5=aching legs, 6=tingling, 7=itching, 8=burning of soles of the feet. Each item is classified with a Likert-type scale of 5 levels, where 0=absent, 1=low, 2=medium, 3=high, 4=very high. A total score is calculated from the sum of the scores of all the 8 items and ranges from 0 (complaints absent) to 32 (very high severity).
Outcome measures
| Measure |
Coumarin + Troxerutin
n=382 Participants
Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
|
Placebo
n=388 Participants
Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
|
|---|---|---|
|
Change (Reduction) From Baseline in Local Complaint Severity
|
10.83 score on a scale
Standard Deviation 6.70
|
10.45 score on a scale
Standard Deviation 6.97
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Participants from the ITT population, all eligible participants who received study drug and had at least one efficacy assessment at Visit 1 (28 ± 5 days after start of treatment), with data available for analysis.
The investigator recorded their impression of the overall clinical picture at the end of the treatment period (Week 16), taking into account the clinical picture compared with the Baseline visit. Data is reported for the percentage of participants in each of the following assessment categories: worsening, unchanged, discreet improvement or accentuated improvement.
Outcome measures
| Measure |
Coumarin + Troxerutin
n=340 Participants
Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
|
Placebo
n=356 Participants
Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
|
|---|---|---|
|
Overall Assessment by the Investigator
Worsening
|
0.6 percentage of participants
|
0.8 percentage of participants
|
|
Overall Assessment by the Investigator
Unchanged
|
11.2 percentage of participants
|
14.3 percentage of participants
|
|
Overall Assessment by the Investigator
Discreet improvement
|
25.3 percentage of participants
|
24.4 percentage of participants
|
|
Overall Assessment by the Investigator
Accentuated improvement
|
62.9 percentage of participants
|
60.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Safety Population included all randomized participants who received study drug and had a least one post-Baseline safety assessment.
Adverse events are any unwanted medical occurrences in an individual taking part in a clinical study who is receiving a pharmaceutical product. The adverse event does not have necessarily a causal relationship with the treatment. In this definition, any adverse or unwanted signals and symptoms, or findings that appear from the start or that deteriorate during the clinical study are also included, i.e. any intercurrent diseases (recently diagnosed concomitant diseases or symptoms), accidents and clinically relevant changes in clinical laboratory values.
Outcome measures
| Measure |
Coumarin + Troxerutin
n=394 Participants
Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
|
Placebo
n=398 Participants
Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
131 participants
|
120 participants
|
Adverse Events
Coumarin + Troxerutin
Serious events: 3 serious events
Other events: 115 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 81 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Coumarin + Troxerutin
n=394 participants at risk
Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
|
Placebo
n=398 participants at risk
Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
|
|---|---|---|
|
Surgical and medical procedures
Varicose vein operation
|
0.25%
1/394 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
0.50%
2/398 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
|
Surgical and medical procedures
Phlebectomy
|
0.25%
1/394 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
0.00%
0/398 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyoma
|
0.25%
1/394 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
0.00%
0/398 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
Other adverse events
| Measure |
Coumarin + Troxerutin
n=394 participants at risk
Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
|
Placebo
n=398 participants at risk
Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.0%
12/394 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
1.5%
6/398 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
|
Gastrointestinal disorders
Gastritis
|
1.8%
7/394 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
1.8%
7/398 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
8/394 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
0.50%
2/398 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.3%
5/394 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
0.75%
3/398 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
|
Gastrointestinal disorders
Constipation
|
1.3%
5/394 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
0.25%
1/398 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
|
General disorders
Influenza like illness
|
1.0%
4/394 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
0.75%
3/398 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
|
Infections and infestations
Influenza
|
1.0%
4/394 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
3.8%
15/398 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
|
Infections and infestations
Tonsillitis
|
1.8%
7/394 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
1.3%
5/398 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
|
Infections and infestations
Urinary tract infection
|
1.5%
6/394 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
1.5%
6/398 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.8%
7/394 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
0.75%
3/398 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
|
Investigations
Alanine aminotransferase increased
|
1.0%
4/394 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
0.00%
0/398 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
|
Investigations
Aspartate aminotransferase increased
|
1.0%
4/394 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
0.00%
0/398 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
|
Metabolism and nutrition disorders
Obesity
|
1.3%
5/394 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
0.75%
3/398 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.3%
5/394 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
0.25%
1/398 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
|
Nervous system disorders
Headache
|
4.1%
16/394 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
2.5%
10/398 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
|
Nervous system disorders
Dizziness
|
1.0%
4/394 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
0.75%
3/398 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.51%
2/394 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
1.3%
5/398 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.76%
3/394 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
1.0%
4/398 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
|
Vascular disorders
Hypertension not otherwise specified (NOS)
|
1.8%
7/394 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
1.0%
4/398 • From the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator documented any occurrence of adverse events. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. Safety Population: all randomized participants who received study drug and had a least one post-Baseline safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 30 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results.
- Publication restrictions are in place
Restriction type: OTHER