Trial Outcomes & Findings for Olmesartan/HCTZ 40/12.5 mg Combination Therapy Versus Olmesartan Medoxomil 40 mg Monotherapy in Essential Hypertension (NCT NCT00441350)
NCT ID: NCT00441350
Last Updated: 2021-07-28
Results Overview
Reduction in Mean Trough Sitting dBP (mmHg) from Baseline (Week 0) to Week 8
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1004 participants
Primary outcome timeframe
Eight weeks
Results posted on
2021-07-28
Participant Flow
Participants who completed the arms OM 40 mg and OM/HCTZ 40/12.5 mg, respectively in Phase A are the same ones who started, depending on being a responder or non-responder in the arms of Phase B continuing with OM 40 mg and OM/HCTZ 40/12.5 mg or uptitration to OM/HCTZ 40/12.5 mg and OM/HCTZ 40/25, respectively of Phase B.
Participant milestones
| Measure |
Phase A/OM 40
Olmesartanmedoxomil (OM)40 mg tablets. OM 40: Initially patients were to be treated with Olmesartanmedoxomil (OM)40 mg tablets once daily for 8 weeks. After 8 weeks non-responders were to be uptitrated to OM/HCTZ 40/12.5 mg and responders remained on the previous therapy for further 8 weeks.
|
Phase A/OM/HCTZ 40/12.5
Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets. OM/HCTZ 40/12.5: Initially patients were to be treated with Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets once daily for 8 weeks. After 8 weeks non-responders were to be uptitrated to OM/HCTZ 40/25 mg and responders remained on the previous therapy for further 8 weeks.
|
Phase B/ OM 40 mg Responders
Phase B (second double-blind treatment phase, 8 weeks duration):
Responders to OM 40 mg treatment were to continue treatment with OM 40 mg.
|
Phase B/ OM 40 mg Non-responder
Phase B (second double-blind treatment phase, 8 weeks duration):
Non-responders to OM 40 mg treatment were to be up-titrated to OM/HCTZ 40/12.5 mg.
|
Phase B OM/HCTZ 40/12.5 mg Responders
Phase B (second double-blind treatment phase, 8 weeks duration):
Responders to OM/HCTZ 40/12.5 mg treatment were to continue treatment with OM/HCTZ 40/12.5 mg.
|
Phase B/ OM/HCTZ 40/12.5 mg Non-responders
Phase B (second double-blind treatment phase, 8 weeks duration):
Non-responders to OM/HCTZ 40/12.5 mg treatment were to be up- titrated to OM/HCTZ 40/25 mg.
|
|---|---|---|---|---|---|---|
|
Phase A: Randomization to Week 8
STARTED
|
285
|
561
|
0
|
0
|
0
|
0
|
|
Phase A: Randomization to Week 8
COMPLETED
|
268
|
524
|
0
|
0
|
0
|
0
|
|
Phase A: Randomization to Week 8
NOT COMPLETED
|
17
|
37
|
0
|
0
|
0
|
0
|
|
Phase B: Week 8 to Week 16
STARTED
|
0
|
0
|
129
|
139
|
336
|
188
|
|
Phase B: Week 8 to Week 16
COMPLETED
|
0
|
0
|
128
|
137
|
333
|
186
|
|
Phase B: Week 8 to Week 16
NOT COMPLETED
|
0
|
0
|
1
|
2
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Olmesartan/HCTZ 40/12.5 mg Combination Therapy Versus Olmesartan Medoxomil 40 mg Monotherapy in Essential Hypertension
Baseline characteristics by cohort
| Measure |
OM 40
n=285 Participants
Olmesartanmedoxomil (OM)40 mg tablets.
OM 40: Initially patients were to be treated with Olmesartanmedoxomil (OM)40 mg tablets once daily for 8 weeks. After 8 weeks non-responders were to be uptitrated to OM/HCTZ 40/12.5 mg and responders remained on the previous therapy for further 8 weeks.
|
OM/HCTZ 40/12.5
n=561 Participants
Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets.
OM/HCTZ 40/12.5: Initially patients were to be treated with Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets once daily for 8 weeks. After 8 weeks non-responders were to be uptitrated to OM/HCTZ 40/25 mg and responders remained on the previous therapy for further 8 weeks.
|
Total
n=846 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
|
|
Age, Categorical
Between 18 and 65 years
|
211 Participants
n=5 Participants
|
454 Participants
n=7 Participants
|
665 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
74 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Age, Continuous
|
56.0 years
STANDARD_DEVIATION 11.46 • n=5 Participants
|
55.5 years
STANDARD_DEVIATION 10.57 • n=7 Participants
|
55.6 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
128 Participants
n=5 Participants
|
267 Participants
n=7 Participants
|
395 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
157 Participants
n=5 Participants
|
294 Participants
n=7 Participants
|
451 Participants
n=5 Participants
|
|
Trough Sitting dBP
|
104.5 mmHg
STANDARD_DEVIATION 4.0 • n=5 Participants
|
104.6 mmHg
STANDARD_DEVIATION 4.2 • n=7 Participants
|
104.6 mmHg
STANDARD_DEVIATION 4.1 • n=5 Participants
|
|
Trough Sitting sBP
|
168.0 mmHg
STANDARD_DEVIATION 7.7 • n=5 Participants
|
168.5 mmHg
STANDARD_DEVIATION 8.4 • n=7 Participants
|
168.3 mmHg
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Body Mass Index
|
29.64 kg.m^2
STANDARD_DEVIATION 4.8 • n=5 Participants
|
29.17 kg.m^2
STANDARD_DEVIATION 4.665 • n=7 Participants
|
29.35 kg.m^2
STANDARD_DEVIATION 4.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Eight weeksReduction in Mean Trough Sitting dBP (mmHg) from Baseline (Week 0) to Week 8
Outcome measures
| Measure |
OM 40
n=282 Participants
Olmesartanmedoxomil (OM)40 mg tablets. OM 40: Initially patients were to be treated with Olmesartanmedoxomil (OM)40 mg tablets once daily for 8 weeks.
|
OM/HCTZ 40/12.5
n=556 Participants
Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets. OM/HCTZ 40/12.5: Initially patients were to be treated with Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets once daily for 8 weeks.
|
OM/HCTZ 40/12.5 mg Responders
Phase B (second double-blind treatment phase, 8 weeks duration):
Responders to OM/HCTZ 40/12.5 mg treatment were to continue treatment with OM/HCTZ 40/12.5 mg.
|
OM/HCTZ 40/12.5 mg Non-responders
Phase B (second double-blind treatment phase, 8 weeks duration):
Non-responders to OM/HCTZ 40/12.5 mg treatment were to be up- titrated to OM/HCTZ 40/25 mg.
|
|---|---|---|---|---|
|
dBP Change After 8 Weeks Phase A
|
-15.8 mmHG
Standard Deviation 9.71
|
-18.9 mmHG
Standard Deviation 9.32
|
—
|
—
|
PRIMARY outcome
Timeframe: Eight weeksReduction in Mean Trough Sitting sBP (mmHg) from Baseline (Week 0) to Week 8
Outcome measures
| Measure |
OM 40
n=282 Participants
Olmesartanmedoxomil (OM)40 mg tablets. OM 40: Initially patients were to be treated with Olmesartanmedoxomil (OM)40 mg tablets once daily for 8 weeks.
|
OM/HCTZ 40/12.5
n=556 Participants
Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets. OM/HCTZ 40/12.5: Initially patients were to be treated with Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets once daily for 8 weeks.
|
OM/HCTZ 40/12.5 mg Responders
Phase B (second double-blind treatment phase, 8 weeks duration):
Responders to OM/HCTZ 40/12.5 mg treatment were to continue treatment with OM/HCTZ 40/12.5 mg.
|
OM/HCTZ 40/12.5 mg Non-responders
Phase B (second double-blind treatment phase, 8 weeks duration):
Non-responders to OM/HCTZ 40/12.5 mg treatment were to be up- titrated to OM/HCTZ 40/25 mg.
|
|---|---|---|---|---|
|
sBP Change After 8 Weeks Phase A
|
-26.5 mmHG
Standard Deviation 14.56
|
-31.9 mmHG
Standard Deviation 14.76
|
—
|
—
|
SECONDARY outcome
Timeframe: Eight weeksReduction in trough sitting diastolic blood pressure after 8 weeks of additional treatment, depending on Phase A treatment and outcome (responder/non-responder).
Outcome measures
| Measure |
OM 40
n=129 Participants
Olmesartanmedoxomil (OM)40 mg tablets. OM 40: Initially patients were to be treated with Olmesartanmedoxomil (OM)40 mg tablets once daily for 8 weeks.
|
OM/HCTZ 40/12.5
n=139 Participants
Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets. OM/HCTZ 40/12.5: Initially patients were to be treated with Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets once daily for 8 weeks.
|
OM/HCTZ 40/12.5 mg Responders
n=336 Participants
Phase B (second double-blind treatment phase, 8 weeks duration):
Responders to OM/HCTZ 40/12.5 mg treatment were to continue treatment with OM/HCTZ 40/12.5 mg.
|
OM/HCTZ 40/12.5 mg Non-responders
n=187 Participants
Phase B (second double-blind treatment phase, 8 weeks duration):
Non-responders to OM/HCTZ 40/12.5 mg treatment were to be up- titrated to OM/HCTZ 40/25 mg.
|
|---|---|---|---|---|
|
dBP Change After 8 Weeks Phase B
|
-0.5 mmHg
Standard Deviation 6.95
|
-9.3 mmHg
Standard Deviation 7.91
|
-0.3 mmHg
Standard Deviation 6.68
|
-8.0 mmHg
Standard Deviation 8.56
|
SECONDARY outcome
Timeframe: Eight weeksReduction in trough sitting systolic blood pressure after 8 weeks of additional treatment, depending on Phase A treatment and outcome (responder/non-responder).
Outcome measures
| Measure |
OM 40
n=129 Participants
Olmesartanmedoxomil (OM)40 mg tablets. OM 40: Initially patients were to be treated with Olmesartanmedoxomil (OM)40 mg tablets once daily for 8 weeks.
|
OM/HCTZ 40/12.5
n=139 Participants
Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets. OM/HCTZ 40/12.5: Initially patients were to be treated with Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets once daily for 8 weeks.
|
OM/HCTZ 40/12.5 mg Responders
n=336 Participants
Phase B (second double-blind treatment phase, 8 weeks duration):
Responders to OM/HCTZ 40/12.5 mg treatment were to continue treatment with OM/HCTZ 40/12.5 mg.
|
OM/HCTZ 40/12.5 mg Non-responders
n=187 Participants
Phase B (second double-blind treatment phase, 8 weeks duration):
Non-responders to OM/HCTZ 40/12.5 mg treatment were to be up- titrated to OM/HCTZ 40/25 mg.
|
|---|---|---|---|---|
|
sBP Change After 8 Weeks Phase B
|
-0.5 mmHg
Standard Deviation 6.95
|
-12.4 mmHg
Standard Deviation 11.64
|
-0.4 mmHg
Standard Deviation 9.32
|
-12.1 mmHg
Standard Deviation 12.69
|
Adverse Events
Phase B OM/HCTZ 40/12.5 mg Non-responders
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Phase B OM/HCTZ 40/12.5 mg Responders
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Phase B OM 40 mg Non-responders
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase B OM 40 mg Responders
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Phase A OM/HCTZ 40/12.5 mg
Serious events: 4 serious events
Other events: 41 other events
Deaths: 0 deaths
Phase A OM 40 mg
Serious events: 5 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase B OM/HCTZ 40/12.5 mg Non-responders
n=188 participants at risk
Phase B (second double-blind treatment phase, 8 weeks duration):
Non-responders to OM/HCTZ 40/12.5 mg treatment were to be up- titrated to OM/HCTZ 40/25 mg.
|
Phase B OM/HCTZ 40/12.5 mg Responders
n=336 participants at risk
Phase B (second double-blind treatment phase, 8 weeks duration):
Responders to OM/HCTZ 40/12.5 mg treatment were to continue treatment with OM/HCTZ 40/12.5 mg.
|
Phase B OM 40 mg Non-responders
n=139 participants at risk
Phase B (second double-blind treatment phase, 8 weeks duration):
Non-responders to OM 40 mg treatment were to be up-titrated to OM/HCTZ 40/12.5 mg.
|
Phase B OM 40 mg Responders
n=129 participants at risk
Phase B (second double-blind treatment phase, 8 weeks duration):
Responders to OM 40 mg treatment were to continue treatment with OM 40 mg.
|
Phase A OM/HCTZ 40/12.5 mg
n=561 participants at risk
Phase A (first double-blind treatment phase, 8 weeks duration):
Arm 2: OM/HCTZ 40/12.5 mg tablet o.d.
|
Phase A OM 40 mg
n=285 participants at risk
Phase A (first double-blind treatment phase, 8 weeks duration):
Arm 1: OM 40 mg tablet o.d.
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Anal fissure
|
0.53%
1/188 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/336 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/139 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/129 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/561 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/285 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/188 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.30%
1/336 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/139 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/129 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/561 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/285 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/188 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.30%
1/336 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/139 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/129 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/561 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/285 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/188 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/336 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/139 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/129 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/561 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.35%
1/285 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/188 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/336 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/139 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/129 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.18%
1/561 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/285 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Duodenal ulcer
|
0.00%
0/188 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/336 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/139 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/129 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/561 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.35%
1/285 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/188 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/336 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/139 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/129 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.18%
1/561 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/285 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
|
Nervous system disorders
Syncope
|
0.00%
0/188 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/336 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/139 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/129 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/561 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.35%
1/285 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
|
Nervous system disorders
Brain contusion
|
0.00%
0/188 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.30%
1/336 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/139 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/129 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/561 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/285 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/188 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/336 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/139 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/129 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.18%
1/561 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/285 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/188 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/336 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/139 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/129 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/561 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.35%
1/285 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/188 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/336 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/139 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/129 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/561 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.35%
1/285 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
|
Cardiac disorders
Incontinence
|
0.00%
0/188 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/336 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/139 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/129 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/561 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.35%
1/285 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
|
Gastrointestinal disorders
Palpitations
|
0.00%
0/188 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.30%
1/336 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/139 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/129 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/561 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/285 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
|
Gastrointestinal disorders
Chest pain
|
0.00%
0/188 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.30%
1/336 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/139 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/129 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/561 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/285 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/188 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/336 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/139 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.78%
1/129 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/561 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/285 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/188 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/336 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/139 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/129 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.18%
1/561 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/285 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/188 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/336 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/139 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/129 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/561 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.35%
1/285 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
|
Infections and infestations
Parotid abscess
|
0.00%
0/188 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/336 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/139 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/129 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/561 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.35%
1/285 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
|
Infections and infestations
Erysipeloid
|
0.00%
0/188 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/336 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/139 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.78%
1/129 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/561 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/285 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
Other adverse events
| Measure |
Phase B OM/HCTZ 40/12.5 mg Non-responders
n=188 participants at risk
Phase B (second double-blind treatment phase, 8 weeks duration):
Non-responders to OM/HCTZ 40/12.5 mg treatment were to be up- titrated to OM/HCTZ 40/25 mg.
|
Phase B OM/HCTZ 40/12.5 mg Responders
n=336 participants at risk
Phase B (second double-blind treatment phase, 8 weeks duration):
Responders to OM/HCTZ 40/12.5 mg treatment were to continue treatment with OM/HCTZ 40/12.5 mg.
|
Phase B OM 40 mg Non-responders
n=139 participants at risk
Phase B (second double-blind treatment phase, 8 weeks duration):
Non-responders to OM 40 mg treatment were to be up-titrated to OM/HCTZ 40/12.5 mg.
|
Phase B OM 40 mg Responders
n=129 participants at risk
Phase B (second double-blind treatment phase, 8 weeks duration):
Responders to OM 40 mg treatment were to continue treatment with OM 40 mg.
|
Phase A OM/HCTZ 40/12.5 mg
n=561 participants at risk
Phase A (first double-blind treatment phase, 8 weeks duration):
Arm 2: OM/HCTZ 40/12.5 mg tablet o.d.
|
Phase A OM 40 mg
n=285 participants at risk
Phase A (first double-blind treatment phase, 8 weeks duration):
Arm 1: OM 40 mg tablet o.d.
|
|---|---|---|---|---|---|---|
|
Vascular disorders
Hypertension
|
1.1%
2/188 • Number of events 2 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.60%
2/336 • Number of events 2 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/139 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/129 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/561 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/285 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/188 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/336 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/139 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/129 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.36%
2/561 • Number of events 2 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
1.8%
5/285 • Number of events 5 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/188 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/336 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/139 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/129 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
1.8%
10/561 • Number of events 10 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/285 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
|
Nervous system disorders
Headache
|
0.53%
1/188 • Number of events 1 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.60%
2/336 • Number of events 2 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
1.4%
2/139 • Number of events 2 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.78%
1/129 • Number of events 1 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
1.6%
9/561 • Number of events 9 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
2.1%
6/285 • Number of events 6 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/188 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.30%
1/336 • Number of events 1 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/139 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
1.6%
2/129 • Number of events 2 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/561 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/285 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.1%
2/188 • Number of events 2 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.30%
1/336 • Number of events 1 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/139 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/129 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/561 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/285 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.1%
2/188 • Number of events 2 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.60%
2/336 • Number of events 2 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.72%
1/139 • Number of events 1 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.78%
1/129 • Number of events 1 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/561 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/285 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
|
Gastrointestinal disorders
Hypertriglyceridaemia
|
0.00%
0/188 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
1.2%
4/336 • Number of events 4 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.72%
1/139 • Number of events 1 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/129 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/561 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/285 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
|
Infections and infestations
Bronchitis
|
1.1%
2/188 • Number of events 2 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.60%
2/336 • Number of events 2 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.00%
0/139 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
1.6%
2/129 • Number of events 2 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
1.1%
6/561 • Number of events 6 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
1.1%
3/285 • Number of events 3 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/188 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
0.60%
2/336 • Number of events 2 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
1.4%
2/139 • Number of events 2 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
1.6%
2/129 • Number of events 2 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
2.5%
14/561 • Number of events 14 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
1.8%
5/285 • Number of events 5 • The study consisted of two sequential phases A and B of 8 weeks duration each.
Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.
|
Additional Information
Angela Capriati, MD PhD - Global Director Clinical Sciences
Menarini Group
Phone: +39 055 5680
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place