Trial Outcomes & Findings for Efficacy and Safety of Olmesartan Medoxomil in Stage 1 and 2 Essential Hypertension (NCT NCT00890591)

Results Overview

Number of patients that achieved a blood pressure (BP) goal of less than 130/85 in the first group (olmesartan monotherapy 20 mg). If BP was \> or = to 140/90 at 4,8, or 9 wks the participant went to next level for an additional 4-9 weeks at the next medication level

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

144 participants

Primary outcome timeframe

4 - 9 wks of olmesartan monotherapy

Results posted on

2009-06-03

Participant Flow

The study pop. was defined by the inclusion criteria. This study was carried out in 14 centers in Brazil with inclusion 2 months after the first study subject, started in Aug 06. After the screening visit, the patients that met inclusion and exclusion criteria were selected to participate in the study. The last patient out was in Jul 07.

A wash out period was needed in case of a previous inefficient antihypertensive medication, so it was interrupted from 2 to 3 wks before the enrollment. The patient could be excluded considering the exclusion criteria.

Participant milestones

Participant milestones
Measure	Olmesartan + Hydrochlorothiazide + Amlodipine 1. olmesartan monotherapy was the starting dosage regimen. Blood pressure (BP) measurments were obtained at 4, 8 and 9 weeks. If BP goals were not met at a measurment point the participant's medication was elevated to the next step and BP measurments taken at the next 4, 8, and 9 weeks. 2. olmesartan 20 mg/ hydrochlorothiazide 12.5 mg tablets was the first titration regimen if blood pressure goals were not achieved 3. olmesartan 40 mg + hydrochlorothiazide 25 mg tablets was the second titration regimen if blood pressure goals were not achieved 4. olmesartan 40 mg + hydrochlorothiazide 25 mg tablets + amlodipine 5 mg tablets was the third titration regimen if blood pressure goals were not achieved
Overall Study STARTED	144
Overall Study COMPLETED	124
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Reasons for withdrawal
Measure	Olmesartan + Hydrochlorothiazide + Amlodipine 1. olmesartan monotherapy was the starting dosage regimen. Blood pressure (BP) measurments were obtained at 4, 8 and 9 weeks. If BP goals were not met at a measurment point the participant's medication was elevated to the next step and BP measurments taken at the next 4, 8, and 9 weeks. 2. olmesartan 20 mg/ hydrochlorothiazide 12.5 mg tablets was the first titration regimen if blood pressure goals were not achieved 3. olmesartan 40 mg + hydrochlorothiazide 25 mg tablets was the second titration regimen if blood pressure goals were not achieved 4. olmesartan 40 mg + hydrochlorothiazide 25 mg tablets + amlodipine 5 mg tablets was the third titration regimen if blood pressure goals were not achieved
Overall Study Lack of Efficacy	20

Baseline Characteristics

Efficacy and Safety of Olmesartan Medoxomil in Stage 1 and 2 Essential Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Olmesartan + Hydrochlorothiazide + Amlodipine n=144 Participants 1. olmesartan monotherapy was the starting dosage regimen. Blood pressure (BP) measurments were obtained at 4, 8 and 9 weeks. If BP goals were not met at a measurment point the participant's medication was elevated to the next step and BP measurments taken at the next 4, 8, and 9 weeks. 2. olmesartan 20 mg/ hydrochlorothiazide 12.5 mg tablets was the first titration regimen if blood pressure goals were not achieved 3. olmesartan 40 mg + hydrochlorothiazide 25 mg tablets was the second titration regimen if blood pressure goals were not achieved 4. olmesartan 40 mg + hydrochlorothiazide 25 mg tablets + amlodipine 5 mg tablets was the third titration regimen if blood pressure goals were not achieved
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	132 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Sex: Female, Male Female	74 Participants n=5 Participants
Sex: Female, Male Male	70 Participants n=5 Participants
Race/Ethnicity, Customized Black	24 Participants n=5 Participants
Race/Ethnicity, Customized White	83 Participants n=5 Participants
Race/Ethnicity, Customized Asian	7 Participants n=5 Participants
Race/Ethnicity, Customized Other	30 Participants n=5 Participants
Region of Enrollment Brazil	144 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 - 9 wks of olmesartan monotherapy

Population: In this first dosage group 144 started and 38 patients met their blood pressure goal; therefore, 106 started the first titration regimen. There were no dropouts.

Number of patients that achieved a blood pressure (BP) goal of less than 130/85 in the first group (olmesartan monotherapy 20 mg). If BP was \> or = to 140/90 at 4,8, or 9 wks the participant went to next level for an additional 4-9 weeks at the next medication level

Outcome measures

Outcome measures
Measure	Olmesartan Monotherapy n=144 Participants olmesartan monotherapy 20 mg for 4-9 weeks based on blood pressure (BP) measurements at 4, 8 or 9 weeks. Participant went to next treatment if BP \> or = to 140/90 mm Hg
Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 (Olmesartan 20 mg Monotherapy)	38 Participants

PRIMARY outcome

Timeframe: 4 to 9 weeks on combination therapy

Population: In this first titration group 106 patients started and 33 achieved their blood pressure goal. There were no dropouts and 73 subject started the second titration regimen.

Number of patients that achieved a blood pressure goal of less than 130/85 in first titrated group (olmesartan 20 mg + 12.5 mg hydrochlorothiazide)If BP was \> or = to 140/90 at 4,8, or 9 wks the participant went to next level of medication for an additional 4-9 weeks

Outcome measures

Outcome measures
Measure	Olmesartan Monotherapy n=106 Participants olmesartan monotherapy 20 mg for 4-9 weeks based on blood pressure (BP) measurements at 4, 8 or 9 weeks. Participant went to next treatment if BP \> or = to 140/90 mm Hg
Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in First Titrated Group (Olmesartan 20 mg + 12.5 mg Hydrochlorothiazide)	33 Participants

PRIMARY outcome

Timeframe: 4 to 9 weeks

Population: 73 patients started the second titration regimen and 41 met their blood pressure goal. There were no dropouts. 32 started the final titration regimen.

Number of patients that achieved a blood pressure goal of less than 130/85 in second titrated group (olmesartan 40 mg + 25 mg hydrochlorothiazide). If BP was \> or = to 140/90 at 4,8, or 9 wks the participant went to next level of medication for an additional 4-9 weeks.

Outcome measures

Outcome measures
Measure	Olmesartan Monotherapy n=73 Participants olmesartan monotherapy 20 mg for 4-9 weeks based on blood pressure (BP) measurements at 4, 8 or 9 weeks. Participant went to next treatment if BP \> or = to 140/90 mm Hg
Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Second Titrated Group (Olmesartan 40 mg + 25 mg Hydrochlorothiazide)	41 Participants

PRIMARY outcome

Timeframe: 4 - 9 weeks

Population: 32 subjects started the third and final titration regimen and 12 met their blood pressure goals. 20 dropped out for lack of efficacy.

Number of patients that achieved a blood pressure goal of less than 130/85 in third titrated group (olmesartan 40 mg + 25 mg hydrochlorothiazide + amlodipine 5 mg). This combination was maintained as long as the participant's blood pressure remained within predefined parameters. If not, participant discontinued for lack of efficacy.

Outcome measures

Outcome measures
Measure	Olmesartan Monotherapy n=32 Participants olmesartan monotherapy 20 mg for 4-9 weeks based on blood pressure (BP) measurements at 4, 8 or 9 weeks. Participant went to next treatment if BP \> or = to 140/90 mm Hg
Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Third Titrated Group (Olmesartan + Hydrochorothiazide + Amlodipine)	12 Participants

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Howard Kessler

Daiichi Sankyo Pharma Development

Phone: 732-590-5032

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place