Trial Outcomes & Findings for Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension (NCT NCT00430950)
NCT ID: NCT00430950
Last Updated: 2019-01-10
Results Overview
Change in mean trough sitting diastolic Blood Pressure between OM/HCTZ 20/25 mg vs. 40/25 mg, in those patients inadequately controlled on OM 40 mg monotherapy, after eight weeks of double blind treatment, as compared to baseline. Change = Week 16 - Week 8 (baseline).
COMPLETED
PHASE3
1011 participants
8 weeks
2019-01-10
Participant Flow
92 principal investigators screened patients at clinical sites in Europe (8 in Belgium, 17 in Germany, 12 in the Netherlands, 17 in Poland, 19 in Russia, 10 in Slovakia, and 9 in the Ukraine).Sites were either hospitals or general practitioners. First patient in: 05 December 2006 Last patient out: 07 May 2008
Trial is 2 week taper-off phase and 2 treatment periods. Period I - 8-week open-label OM 40mg. Only non-responders eligible to randomise into Period II. Period II - 8-week double-blind patients assigned into one of two arms. Results provided for Period II only.
Participant milestones
| Measure |
OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo
Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
|
OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo
Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
|
|---|---|---|
|
Overall Study
STARTED
|
502
|
508
|
|
Overall Study
COMPLETED
|
489
|
495
|
|
Overall Study
NOT COMPLETED
|
13
|
13
|
Reasons for withdrawal
| Measure |
OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo
Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
|
OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo
Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
6
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
concomitant medication,etc.
|
5
|
7
|
Baseline Characteristics
Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension
Baseline characteristics by cohort
| Measure |
OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo
n=502 Participants
Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
|
OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo
n=508 Participants
Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
|
Total
n=1010 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0.0 Participants
n=5 Participants
|
|
Age, Customized
Between 18 and 65 years
|
404 Participants
n=5 Participants
|
422 Participants
n=7 Participants
|
826.0 Participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
93 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
168.0 Participants
n=5 Participants
|
|
Age, Customized
>= 75 years
|
5 Participants
1.0 • n=5 Participants
|
11 Participants
2.2 • n=7 Participants
|
16.0 Participants
n=5 Participants
|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 9.67 • n=5 Participants
|
54.4 years
STANDARD_DEVIATION 9.77 • n=7 Participants
|
54.6 years
STANDARD_DEVIATION 9.72 • n=5 Participants
|
|
Sex: Female, Male
Female
|
194 Participants
n=5 Participants
|
201 Participants
n=7 Participants
|
395 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
308 Participants
n=5 Participants
|
307 Participants
n=7 Participants
|
615 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
European
|
502 participants
n=5 Participants
|
508 participants
n=7 Participants
|
1010 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: The main analysis will be performed on the full analysis set last observation carried forward (LOCF). Pooling will be applied for small centres.
Change in mean trough sitting diastolic Blood Pressure between OM/HCTZ 20/25 mg vs. 40/25 mg, in those patients inadequately controlled on OM 40 mg monotherapy, after eight weeks of double blind treatment, as compared to baseline. Change = Week 16 - Week 8 (baseline).
Outcome measures
| Measure |
OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo
n=502 Participants
Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
|
OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo
n=508 Participants
Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
|
|---|---|---|
|
Change in Mean Trough Sitting Diastolic Blood Pressure
|
-11.16 mm Hg
Standard Deviation 8.851
|
-10.45 mm Hg
Standard Deviation 7.928
|
SECONDARY outcome
Timeframe: 4 weeksChange = Week 12 - Week 8 (baseline).
Outcome measures
| Measure |
OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo
n=502 Participants
Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
|
OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo
n=508 Participants
Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
|
|---|---|---|
|
Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12
|
-9.32 mm Hg
Standard Deviation 7.820
|
-8.83 mm Hg
Standard Deviation 7.584
|
SECONDARY outcome
Timeframe: 8 weeks4 weeks Change = Week 12 - Week 8 (baseline). 8 weeks Change = Week 16 - Week 8 (baseline).
Outcome measures
| Measure |
OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo
n=502 Participants
Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
|
OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo
n=508 Participants
Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
|
|---|---|---|
|
Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline.
Change from baseline (Week 8) to Week 16 in sBP
|
-17.41 mm Hg
Standard Deviation 13.930
|
-17.09 mm Hg
Standard Deviation 13.126
|
|
Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline.
Change from baseline (Week 8) to Week 12 in sBP
|
-14.07 mm Hg
Standard Deviation 12.654
|
-13.80 mm Hg
Standard Deviation 12.519
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Exploratory analysis: ANCOVA was used to compare the differences in change from baseline (Visit 4, Week 8) to Week 16 (Visit 6) in daytime, nighttime and 24-hr ABPM dBP and sBP.
Change = Week 16 - Week 8 (baseline).
Outcome measures
| Measure |
OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo
n=442 Participants
Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
|
OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo
n=442 Participants
Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
|
|---|---|---|
|
Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline.
Change from Week 8 to Wk 16 in mean 24-hr ABPM dBP
|
-9.2 mm Hg
Standard Deviation 8.69
|
-7.6 mm Hg
Standard Deviation 8.03
|
|
Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline.
Change from Week 8 to wk16 in daytime ABPM dBP
|
-9.3 mm Hg
Standard Deviation 9.18
|
-7.7 mm Hg
Standard Deviation 8.48
|
|
Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline.
Change from Week 8 to wk16 in nighttime ABPM dBP
|
-8.6 mm Hg
Standard Deviation 9.52
|
-7.0 mm Hg
Standard Deviation 9.49
|
|
Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline.
Change from Week 8 to wk16 in mean 24-hr ABPM sBP
|
-14.7 mm Hg
Standard Deviation 13.75
|
-12.0 mm Hg
Standard Deviation 11.81
|
|
Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline.
Change from Week 8 to wk16 in daytime ABPM sBP
|
-15.0 mm Hg
Standard Deviation 14.36
|
-12.3 mm Hg
Standard Deviation 12.45
|
|
Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline.
Change from Week 8 to wk16 in nighttime ABPM sBP
|
-13.4 mm Hg
Standard Deviation 14.59
|
-10.7 mm Hg
Standard Deviation 13.16
|
SECONDARY outcome
Timeframe: 8 weeksOutcome measures
| Measure |
OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo
n=502 Participants
Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
|
OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo
n=508 Participants
Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
|
|---|---|---|
|
Number of Participants Achieving Blood Pressure Goal.
|
260 participants
|
255 participants
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
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