Trial Outcomes & Findings for Olmesartan Medoxomil Versus Losartan in Patients With Hypertension (NCT NCT00857285)

NCT ID: NCT00857285

Last Updated: 2009-07-23

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 130 participants
• Primary outcome timeframe: Baseline to 12 weeks
• Results posted on: 2009-07-23

Participant Flow

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.

After a taper off period for 1 week, if necessary, and a placebo run-in period for 2 weeks, 130 subjects were randomized to olmesartan 20mg and losartan 50mg by 1:1 ratio.

Participant milestones

Measure	Olmesartan Medoxomil olmesartan medoxomil oral tablets, once daily for up to 12 weeks	Losartan Potassium losartan potassium oral tablets, once daily for up to 12 weeks
Overall Study STARTED	65	65
Overall Study COMPLETED	53	59
Overall Study NOT COMPLETED	12	6

Reasons for withdrawal

Measure	Olmesartan Medoxomil olmesartan medoxomil oral tablets, once daily for up to 12 weeks	Losartan Potassium losartan potassium oral tablets, once daily for up to 12 weeks
Overall Study Adverse Event	4	2
Overall Study Lack of Efficacy	0	2
Overall Study Protocol Violation	3	1
Overall Study Withdrawal by Subject	4	0
Overall Study Randomization criteria not met	1	1

Baseline Characteristics

Olmesartan Medoxomil Versus Losartan in Patients With Hypertension

Baseline characteristics by cohort

Measure	Olmesartan Medoxomil n=65 Participants olmesartan medoxomil oral tablets, once daily for up to 12 weeks	Losartan Potassium n=65 Participants losartan potassium oral tablets, once daily for up to 12 weeks	Total n=130 Participants Total of all reporting groups
Age Continuous	49.63 years STANDARD_DEVIATION 10.69 • n=5 Participants	48.34 years STANDARD_DEVIATION 9.17 • n=7 Participants	48.98 years STANDARD_DEVIATION 9.94 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	23 Participants n=7 Participants	56 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	42 Participants n=7 Participants	74 Participants n=5 Participants
Race/Ethnicity, Customized Taiwanese	65 participants n=5 Participants	65 participants n=7 Participants	130 participants n=5 Participants
Region of Enrollment Taiwan	65 participants n=5 Participants	65 participants n=7 Participants	130 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Population: Four randomized subjects (3 in olmesartan, 1 in losartan) were excluded from the analysis due to a lack of post-treatment efficacy evaluation.

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.

Outcome measures

Measure	Olmesartan Medoxomil n=62 Participants olmesartan medoxomil oral tablets, once daily for up to 12 weeks	Losartan Potassium n=64 Participants losartan potassium oral tablets, once daily for up to 12 weeks
Mean Change of Sitting dBP From Baseline to Week 12	-14.80 mmHg Standard Error 12.50	-11.60 mmHg Standard Error 9.46

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Director, Regulatory Operations

Daiichi Sankyo, Inc.

Phone: 732-590-5000

Email: hmkessler@dsus.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place