A Phase 3 interventional study of olmesartan medoxomil and losartan potassium in Essential Hypertension, sponsored by Daiichi Sankyo. Completed at 3 sites in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2009-07-23.
Sponsored by Daiichi Sankyo · Phase 3, Interventional, and Treatment
The purpose of this study is to determine the efficacy and safety of oral administration of olmesartan medoxomil compared to losartan in subjects with mild to moderate hypertension.
538 studies on the registry are indexed under Essential Hypertension; 76 are open to participants now.
This study's enrollment of 130 is below the median of 166 across 458 interventional studies indexed under Essential Hypertension.
Browse Essential Hypertension studies →Daiichi Sankyo is the lead sponsor of 322 studies on the registry; 37 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 38 (75%) have results posted.
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Exclusion Criteria:
olmesartan medoxomil
Drug: olmesartan medoxomil
losartan potassium
Drug: losartan potassium
olmesartan medoxomil oral tablets, once daily for up to 12 weeks
losartan oral tablets, once daily for up to 12 weeks
Mean Change of Sitting dBP From Baseline to Week 12
The difference in the sitting diastolic blood pressure (dBP) at trough, i.e. 24±2 hours after drug administration, from base line to Week 12.
Time frame: Baseline to 12 weeks
A total of 181 subjects were screened at 3 study sites in Taiwan from May 2002 to April 2003, and 51 subjects had dropped as screen failure.
| Milestone | Olmesartan Medoxomil | Losartan Potassium |
|---|---|---|
| Started | 65 | 65 |
| Completed | 53 | 59 |
| Not completed | 12 | 6 |
| Withdrew: Adverse event | 4 | 2 |
| Withdrew: Lack of efficacy | 0 | 2 |
| Withdrew: Protocol violation | 3 | 1 |
| Withdrew: Withdrawal by subject | 4 | 0 |
| Withdrew: Randomization criteria not met | 1 | 1 |
The difference in the sitting diastolic blood pressure (dBP) at trough, i.e. 24±2 hours after drug administration, from base line to Week 12.
| mmHg | Olmesartan Medoxomil | Losartan Potassium |
|---|---|---|
| Mean Change of Sitting dBP From Baseline to Week 12 | -14.80 ± 12.50 | -11.60 ± 9.46 |
| Age Continuous(years) | Olmesartan Medoxomil | Losartan Potassium | Total |
|---|---|---|---|
| Mean | 49.63 ± 10.69 | 48.34 ± 9.17 | 48.98 ± 9.94 |
| Sex: Female, Male(Participants) | Olmesartan Medoxomil | Losartan Potassium | Total |
|---|---|---|---|
| Female | 33 | 23 | 56 |
| Male | 32 | 42 | 74 |
| Race/Ethnicity, Customized(participants) | Olmesartan Medoxomil | Losartan Potassium | Total |
|---|---|---|---|
| Taiwanese | 65 | 65 | 130 |
| Region of Enrollment(participants) | Olmesartan Medoxomil | Losartan Potassium | Total |
|---|---|---|---|
| Taiwan | 65 | 65 | 130 |
This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Olmesartan Medoxomil