Trial Outcomes & Findings for Use of the Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension (NCT NCT00430508)
NCT ID: NCT00430508
Last Updated: 2019-01-09
Results Overview
Change = Week 16 - Week 8 (baseline).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
972 participants
Primary outcome timeframe
8 weeks, change = week 16 - week 8
Results posted on
2019-01-09
Participant Flow
78 investigative sites screened patients in Europe (19 in Czech Republic, 11 in Germany, 8 in Bulgaria, 5 in Spain, 20 in Ukraine, 1 in France and 14 in Poland). Sites were either hospitals or general practitioners. First patient in: 17 January 2007 Last patient out: 30 March 2008
Trial is 2-week taper-off phase and 2 treatment periods. Period I-8-week open-label, OM 40mg. End of Period I, only non-responders randomised to Period II. Blood Pressure controlled patients discontinued. Period II-8-week double-blind four randomized treatment arms. Participant flow is Period II. 972 completed period I, 971 started period II.
Participant milestones
| Measure |
OM/HCTZ 40/25mg + 20/12.5 Matching Placebo
olmesartan medoxomil/Hydrochlorothizaide 40/25mg tablets, once daily for 8 weeks
|
OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo
olmesartan medoxomil/Hydrochlorothizaide 40/12.5mg tablets, once daily for 8 weeks
|
OM/HCTZ 20/12.5mg + 40/0 Matching Placebo
olmesartan medoxomil/Hydrochlorothizaide 20/12.5mg tablets, once daily for 8 weeks
|
OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
olmesartan medoxomil/Hydrochlorothizaide 40/0mg tablets, once daily for 8 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
140
|
278
|
279
|
274
|
|
Overall Study
COMPLETED
|
137
|
272
|
266
|
269
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
13
|
5
|
Reasons for withdrawal
| Measure |
OM/HCTZ 40/25mg + 20/12.5 Matching Placebo
olmesartan medoxomil/Hydrochlorothizaide 40/25mg tablets, once daily for 8 weeks
|
OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo
olmesartan medoxomil/Hydrochlorothizaide 40/12.5mg tablets, once daily for 8 weeks
|
OM/HCTZ 20/12.5mg + 40/0 Matching Placebo
olmesartan medoxomil/Hydrochlorothizaide 20/12.5mg tablets, once daily for 8 weeks
|
OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
olmesartan medoxomil/Hydrochlorothizaide 40/0mg tablets, once daily for 8 weeks
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
5
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
1
|
|
Overall Study
responder at visit 4
|
0
|
0
|
2
|
0
|
|
Overall Study
conmed-BP-pulse-ABPM withdrawal criteria
|
0
|
1
|
2
|
1
|
|
Overall Study
Other
|
1
|
1
|
3
|
0
|
Baseline Characteristics
Use of the Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension
Baseline characteristics by cohort
| Measure |
OM/HCTZ 40/25mg + 20/12.5 Matching Placebo
n=140 Participants
olmesartan medoxomil/Hydrochlorothizaide 40/25mg tablets, once daily for 8 weeks
|
OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo
n=278 Participants
olmesartan medoxomil/Hydrochlorothizaide 40/12.5mg tablets, once daily for 8 weeks
|
OM/HCTZ 20/12.5mg + 40/0 Matching Placebo
n=279 Participants
olmesartan medoxomil/Hydrochlorothizaide 20/12.5mg tablets, once daily for 8 weeks
|
OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
n=274 Participants
olmesartan medoxomil/Hydrochlorothizaide 40/0mg tablets, once daily for 8 weeks
|
Total
n=971 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
122 Participants
n=93 Participants
|
240 Participants
n=4 Participants
|
233 Participants
n=27 Participants
|
238 Participants
n=483 Participants
|
833 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
46 Participants
n=27 Participants
|
36 Participants
n=483 Participants
|
138 Participants
n=36 Participants
|
|
Age, Continuous
|
55.2 years
STANDARD_DEVIATION 8.17 • n=93 Participants
|
53.7 years
STANDARD_DEVIATION 9.77 • n=4 Participants
|
55.2 years
STANDARD_DEVIATION 9.47 • n=27 Participants
|
54.1 years
STANDARD_DEVIATION 8.92 • n=483 Participants
|
54.5 years
STANDARD_DEVIATION 9.24 • n=36 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=93 Participants
|
105 Participants
n=4 Participants
|
100 Participants
n=27 Participants
|
115 Participants
n=483 Participants
|
372 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=93 Participants
|
173 Participants
n=4 Participants
|
179 Participants
n=27 Participants
|
159 Participants
n=483 Participants
|
599 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
European
|
140 participants
n=93 Participants
|
278 participants
n=4 Participants
|
278 participants
n=27 Participants
|
274 participants
n=483 Participants
|
970.0 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
0 participants
n=483 Participants
|
1.0 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 8 weeks, change = week 16 - week 8Population: Full Analysis Set-Last Observation Carried Forward.
Change = Week 16 - Week 8 (baseline).
Outcome measures
| Measure |
OM/HCTZ 40/25mg + 20/12.5 Matching Placebo
n=140 Participants
olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
|
OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo
n=277 Participants
olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
|
OM/HCTZ 20/12.5mg + 40/0 Matching Placebo
n=279 Participants
olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
|
OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
n=274 Participants
olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
|
|---|---|---|---|---|
|
Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16
|
-11.16 mm Hg
Standard Deviation 8.796
|
-9.13 mm Hg
Standard Deviation 8.622
|
-8.10 mm Hg
Standard Deviation 7.968
|
-5.66 mm Hg
Standard Deviation 8.546
|
SECONDARY outcome
Timeframe: 4 weeks, change = week 12 - week 8Population: Full Analysis Set-Last Observation Carried Forward
Change = Week 12 - Week 8 (baseline).
Outcome measures
| Measure |
OM/HCTZ 40/25mg + 20/12.5 Matching Placebo
n=140 Participants
olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
|
OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo
n=277 Participants
olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
|
OM/HCTZ 20/12.5mg + 40/0 Matching Placebo
n=279 Participants
olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
|
OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
n=274 Participants
olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
|
|---|---|---|---|---|
|
Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12.
|
-8.74 mm Hg
Standard Deviation 7.879
|
-7.72 mm Hg
Standard Deviation 7.606
|
-6.66 mm Hg
Standard Deviation 7.090
|
-4.47 mm Hg
Standard Deviation 7.197
|
SECONDARY outcome
Timeframe: 8 weeks, change = week 16 - week 8Population: Full Analysis Set-Last Observation Carried Forward.
Change = Week 16 - Week 8 (baseline).
Outcome measures
| Measure |
OM/HCTZ 40/25mg + 20/12.5 Matching Placebo
n=140 Participants
olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
|
OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo
n=277 Participants
olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
|
OM/HCTZ 20/12.5mg + 40/0 Matching Placebo
n=279 Participants
olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
|
OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
n=274 Participants
olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
|
|---|---|---|---|---|
|
Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 16.
|
-16.17 mm Hg
Standard Deviation 13.444
|
-13.52 mm Hg
Standard Deviation 14.533
|
-11.46 mm Hg
Standard Deviation 13.673
|
-8.85 mm Hg
Standard Deviation 13.537
|
SECONDARY outcome
Timeframe: 4 weeks, change = week 12 - week 8Population: Full Analysis Set-Last Observation Carried Forward
Change = Week 12 - Week 8 (baseline).
Outcome measures
| Measure |
OM/HCTZ 40/25mg + 20/12.5 Matching Placebo
n=140 Participants
olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
|
OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo
n=277 Participants
olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
|
OM/HCTZ 20/12.5mg + 40/0 Matching Placebo
n=279 Participants
olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
|
OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
n=274 Participants
olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
|
|---|---|---|---|---|
|
Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 12.
|
-13.16 mm Hg
Standard Deviation 13.337
|
-10.90 mm Hg
Standard Deviation 12.297
|
-9.65 mm Hg
Standard Deviation 11.743
|
-6.60 mm Hg
Standard Deviation 10.932
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Full Analysis Set-Last Observation Carried Forward
Target Blood Pressure is diastolic blood pressure (dBP) \< 90 mmHg and systolic blood pressure (sBP) \< 140 mmHg for non-diabetics, and dBP \< 80 mmHg and sBP \< 130 mmHg for diabetics
Outcome measures
| Measure |
OM/HCTZ 40/25mg + 20/12.5 Matching Placebo
n=140 Participants
olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
|
OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo
n=277 Participants
olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
|
OM/HCTZ 20/12.5mg + 40/0 Matching Placebo
n=279 Participants
olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
|
OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
n=274 Participants
olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
|
|---|---|---|---|---|
|
Number of Patients Achieving Target Blood Pressure at Week 16
|
59 participants
|
110 participants
|
88 participants
|
68 participants
|
SECONDARY outcome
Timeframe: 8 weeks, change = week 16 - week 8Population: Full Analysis Set-Observed Cases
Change = Week 16 - Week 8 (baseline).
Outcome measures
| Measure |
OM/HCTZ 40/25mg + 20/12.5 Matching Placebo
n=120 Participants
olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
|
OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo
n=250 Participants
olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
|
OM/HCTZ 20/12.5mg + 40/0 Matching Placebo
n=241 Participants
olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
|
OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
n=249 Participants
olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
|
|---|---|---|---|---|
|
Change in Mean 24-hour Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.
|
-7.2 mm Hg
Standard Deviation 7.62
|
-5.3 mm Hg
Standard Deviation 8.60
|
-4.1 mm Hg
Standard Deviation 9.07
|
-2.0 mm Hg
Standard Deviation 7.64
|
SECONDARY outcome
Timeframe: 8 weeks, change = week 16 - week 8Population: Full Analysis Set-Observed Cases
Change = Week 16 - Week 8 (baseline).
Outcome measures
| Measure |
OM/HCTZ 40/25mg + 20/12.5 Matching Placebo
n=120 Participants
olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
|
OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo
n=250 Participants
olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
|
OM/HCTZ 20/12.5mg + 40/0 Matching Placebo
n=241 Participants
olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
|
OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
n=249 Participants
olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
|
|---|---|---|---|---|
|
Change in Mean Daytime Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.
|
-7.0 mm Hg
Standard Deviation 8.06
|
-5.5 mm Hg
Standard Deviation 9.10
|
-4.0 mm Hg
Standard Deviation 9.34
|
-1.8 mm Hg
Standard Deviation 8.39
|
SECONDARY outcome
Timeframe: 8 weeks, change = week 16 - week 8Population: Full Analysis Set-Observed Cases
Change = Week 16 - Week 8 (baseline).
Outcome measures
| Measure |
OM/HCTZ 40/25mg + 20/12.5 Matching Placebo
n=120 Participants
olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
|
OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo
n=250 Participants
olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
|
OM/HCTZ 20/12.5mg + 40/0 Matching Placebo
n=241 Participants
olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
|
OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
n=249 Participants
olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
|
|---|---|---|---|---|
|
Change in Mean Night-time Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.
|
-7.9 mm Hg
Standard Deviation 9.51
|
-4.5 mm Hg
Standard Deviation 9.90
|
-4.2 mm Hg
Standard Deviation 10.61
|
-2.3 mm Hg
Standard Deviation 8.47
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
James McCarthy / Director Regulatory Operations
Daiichi Sankyo
Phone: 732-590-3430
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Results of Study shall not be published without prior express written consent and approval of Sponsor. If Contractor wishes to use data generated at Sites by Investigator, such data includes but not limited to data used in collection of metrics, copy of any intended publication, details of use must be sent in writing to Quintiles and Sponsor for review. Sponsor has right to change proposed publication and/or prohibit publication and Contractor must comply with requirements of Sponsor
- Publication restrictions are in place
Restriction type: OTHER