Trial Outcomes & Findings for Efficacy and Safety of Valsartan 160mg and Rosuvastatin 20mg in Patients With Hypertension and Hyperlipidemia (NCT NCT01918332)
NCT ID: NCT01918332
Last Updated: 2014-12-15
Results Overview
sitDBP changes of the valsartan 160mg and valsartan placebo groups at Week 8 from baseline
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
168 participants
Primary outcome timeframe
8 weeks
Results posted on
2014-12-15
Participant Flow
Participant milestones
| Measure |
Placebo
Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.
Valsartan 160mg placebo
Rosuvastatin 20mg placebo
|
Valsartan 160mg, Rosuvastatin 20mg
Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.
Valsartan 160mg
Rosuvastatin 20mg
|
Valsartan 160mg, Rosuvastatin 20mg Placebo
Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.
Valsartan 160mg
Rosuvastatin 20mg placebo
|
Valsartan 160mg Placebo, Rosuvastatin 20mg
Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks.
Rosuvastatin 20mg
Valsartan 160mg placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
45
|
43
|
41
|
39
|
|
Overall Study
COMPLETED
|
38
|
35
|
36
|
30
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
5
|
9
|
Reasons for withdrawal
| Measure |
Placebo
Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.
Valsartan 160mg placebo
Rosuvastatin 20mg placebo
|
Valsartan 160mg, Rosuvastatin 20mg
Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.
Valsartan 160mg
Rosuvastatin 20mg
|
Valsartan 160mg, Rosuvastatin 20mg Placebo
Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.
Valsartan 160mg
Rosuvastatin 20mg placebo
|
Valsartan 160mg Placebo, Rosuvastatin 20mg
Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks.
Rosuvastatin 20mg
Valsartan 160mg placebo
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
3
|
2
|
|
Overall Study
Protocol Violation
|
3
|
6
|
2
|
6
|
|
Overall Study
lipid result by central lab did not meet
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Valsartan 160mg and Rosuvastatin 20mg in Patients With Hypertension and Hyperlipidemia
Baseline characteristics by cohort
| Measure |
Valsartan 160mg, Rosuvastatin 20mg
n=41 Participants
Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.
Valsartan 160mg
Rosuvastatin 20mg
|
Valsartan 160mg, Rosuvastatin 20mg Placebo
n=40 Participants
Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.
Valsartan 160mg
Rosuvastatin 20mg placebo
|
Valsartan 160mg Placebo, Rosuvastatin 20mg
n=35 Participants
Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks.
Rosuvastatin 20mg
Valsartan 160mg placebo
|
Placebo
n=44 Participants
Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.
Valsartan 160mg placebo
Rosuvastatin 20mg placebo
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
100 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
113 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: FAS
sitDBP changes of the valsartan 160mg and valsartan placebo groups at Week 8 from baseline
Outcome measures
| Measure |
V160+R20 & V160
n=81 Participants
Valsartan 160mg + Rosuvastatin 20mg \& Valsartan 160mg + Rosuvastatin 20mg placebo
|
R20 & Placebo
n=79 Participants
Valsartan 160mg placebo + Rosuvastatin 20mg \& Placebo
|
|---|---|---|
|
sitDBP Changes at Week 8 From Baseline
|
-9.24 mmHg
Interval -10.88 to -7.61
|
-2.9 mmHg
Interval -4.55 to -1.24
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: FAS
LDL-C percentage changes of the rosuvastatin 20mg and rosuvastatin placebo groups at Week 8 from baseline
Outcome measures
| Measure |
V160+R20 & V160
n=76 Participants
Valsartan 160mg + Rosuvastatin 20mg \& Valsartan 160mg + Rosuvastatin 20mg placebo
|
R20 & Placebo
n=84 Participants
Valsartan 160mg placebo + Rosuvastatin 20mg \& Placebo
|
|---|---|---|
|
LDL-C Percentage Changes at Week 8 From Baseline
|
-49.91 percent change
Interval -53.34 to -46.47
|
-2.38 percent change
Interval -5.65 to 0.88
|
Adverse Events
Valsartan 160mg, Rosuvastatin 20mg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Valsartan 160mg, Rosuvastatin 20mg Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Valsartan 160mg Placebo, Rosuvastatin 20mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Valsartan 160mg, Rosuvastatin 20mg
n=43 participants at risk
Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.
Valsartan 160mg
Rosuvastatin 20mg
|
Valsartan 160mg, Rosuvastatin 20mg Placebo
n=41 participants at risk
Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.
Valsartan 160mg
Rosuvastatin 20mg placebo
|
Valsartan 160mg Placebo, Rosuvastatin 20mg
n=37 participants at risk
Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks.
Rosuvastatin 20mg
Valsartan 160mg placebo
|
Placebo
n=45 participants at risk
Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.
Valsartan 160mg placebo
Rosuvastatin 20mg placebo
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
2.3%
1/43 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/41 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/37 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/45 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
Other adverse events
| Measure |
Valsartan 160mg, Rosuvastatin 20mg
n=43 participants at risk
Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.
Valsartan 160mg
Rosuvastatin 20mg
|
Valsartan 160mg, Rosuvastatin 20mg Placebo
n=41 participants at risk
Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.
Valsartan 160mg
Rosuvastatin 20mg placebo
|
Valsartan 160mg Placebo, Rosuvastatin 20mg
n=37 participants at risk
Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks.
Rosuvastatin 20mg
Valsartan 160mg placebo
|
Placebo
n=45 participants at risk
Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.
Valsartan 160mg placebo
Rosuvastatin 20mg placebo
|
|---|---|---|---|---|
|
Nervous system disorders
dizziness
|
2.3%
1/43 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
4.9%
2/41 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/37 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/45 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
|
Nervous system disorders
headache
|
4.7%
2/43 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/41 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/37 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
6.7%
3/45 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
|
Nervous system disorders
hypoaesthesia
|
0.00%
0/43 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/41 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
2.7%
1/37 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/45 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
|
Eye disorders
conjunctival haemorrhage
|
0.00%
0/43 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/41 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
2.7%
1/37 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/45 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
|
Gastrointestinal disorders
constipation
|
2.3%
1/43 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/41 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/37 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/45 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
|
Gastrointestinal disorders
dyspepsia
|
2.3%
1/43 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
4.9%
2/41 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/37 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/45 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
|
Infections and infestations
nasopharyngisit
|
0.00%
0/43 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/41 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/37 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
2.2%
1/45 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
|
Gastrointestinal disorders
nausea
|
4.7%
2/43 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/41 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/37 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/45 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
|
General disorders
asthenia
|
0.00%
0/43 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
2.4%
1/41 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
2.7%
1/37 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/45 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
|
General disorders
chest discomfort
|
0.00%
0/43 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
4.9%
2/41 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/37 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/45 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
|
General disorders
chest pain
|
0.00%
0/43 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/41 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
2.7%
1/37 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/45 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
|
General disorders
face oedema
|
2.3%
1/43 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/41 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/37 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/45 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
|
General disorders
oedema peripheral
|
2.3%
1/43 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/41 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/37 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/45 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/43 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/41 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
2.7%
1/37 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/45 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
|
Injury, poisoning and procedural complications
contusion
|
2.3%
1/43 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/41 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/37 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/45 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
|
Investigations
alanine aminotransferase increased
|
2.3%
1/43 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/41 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
2.7%
1/37 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
2.2%
1/45 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
|
Investigations
aspartate aminotransferase increased
|
2.3%
1/43 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/41 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/37 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
2.2%
1/45 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
|
Investigations
blood creatine phosphokinase increased
|
0.00%
0/43 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
2.4%
1/41 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/37 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/45 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
|
Investigations
blood potassium increased
|
0.00%
0/43 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
2.4%
1/41 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/37 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/45 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
|
Investigations
gamma-glutamyltransferase increased
|
0.00%
0/43 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/41 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
2.7%
1/37 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
2.2%
1/45 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal stiffness
|
0.00%
0/43 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
2.4%
1/41 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/37 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/45 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
0.00%
0/43 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/41 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/37 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
2.2%
1/45 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
|
Psychiatric disorders
anxiety
|
2.3%
1/43 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/41 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/37 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/45 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory tract inflammation
|
2.3%
1/43 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/41 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/37 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
0.00%
0/45 • 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period)
All adverse events were collected at every visit by interview, physical assessment and laboratory tests . The following other AE table presents the subject numbers of AE in the first line in the table and the case numbers of AE in the other rows respectively.
|
Additional Information
Prof. YangSoo Jang
Yonsei University Healthcare System Severance Hospital
Phone: 82-2-6924-3109
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER