Essential HypertensionPhase 4BenibestNCT00890591

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

A Phase 4 study testing olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary in people with Essential Hypertension, run by Daiichi Sankyo.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

In patients naive to treatment or after a 2-week washout period for patients whose treatment was ineffective, the use of olmesartan was assessed in a 4-phase treatment scheme: monotherapy, addition of hydrochlorothiazide (2 phases), addition of amlodipine. Read more about this study

Who is it for?: Ages 30 to 70 years
Conditions the study is for: Essential Hypertension
What is being tested?: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 144 participants
Where: No sites listed yet
Study dates: Aug 2006to Aug 2007
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Stage 1 and 2 hypertension without treatment for at least 2 weeks
Women with no risk of becoming pregnant

Who cannot join

Study participation could result in risk to health of subject
Cardiovascular disease
Secondary hypertension or stage 3 hypertension
Myocardial infarction within the last 6 months
Congestive heart failure
Pulmonary edema

Show all 11Show fewer

Valvular alterations or rheumatic cardiopathy
Clinically relevant conduction disorders significant arrhythmias
Alcohol or illicit drug use
Medication abuse
Pregnant or nursing women

About this study

Official title: National, Multicenter, Open-Label and Prospective Study Assessment of Efficacy and Safety in Stage 1 and 2 Essential Hypertension With Olmesartan Medoxomil Based Treatment Algorithm From Monotherapy to Association With Hydrochlorothiazide and Amlodipine Besylate

Conditions: Essential Hypertension
Being tested: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary
Keywords: hypertension, angiotensin II type 1 receptor blocker, olmesartan
Medical subject headings: Essential Hypertension, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessaryDrug
olmesartan medoxomil tablets,or olmesartan medoxomil/hydrochlorothiazide tablets, if necessary + amlodipine tablets, if necessary. All interventions are once-daily for 4 to 9 weeks

Study groups in NCT00890591
Study group	Role	What they receive
Treatment	Experimental	Not described Receives: Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 (Olmesartan 20 mg Monotherapy)
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
Measured: 4 - 9 wks of olmesartan monotherapy
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)
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
Measured: 4 to 9 weeks on combination therapy
Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Second Titrated Group (Olmesartan 40 mg + 25 mg Hydrochlorothiazide)
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.
Measured: 4 to 9 weeks
Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Third Titrated Group (Olmesartan + Hydrochorothiazide + Amlodipine)
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.
Measured: 4 - 9 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2006Aug 2007

First posted30 Apr 2009 (estimated)
Study startAug 2006
Primary completionJun 2007
Study completionAug 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Essential HypertensionStudies of the same condition, open and under way.
More trials run by Daiichi SankyoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 144 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00890591
Sponsor's protocol ID: SPB-OM-0106
Acronym: Benibest
Status last verified: May 2009
First submitted: 11 Feb 2009
Last updated: 3 Jun 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Essential Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: National, Multicenter, Open-Label and Prospective Study Assessment of Efficacy and Safety in Stage 1 and 2 Essential Hypertension With Olmesartan Medoxomil Based Treatment Algorithm From Monotherapy to Association With Hydrochlorothiazide and Amlodipine Besylate
ClinicalTrials.gov ID: NCT00890591
Acronym / sponsor ID: Benibest / SPB-OM-0106
Conditions: Essential Hypertension
Keywords: hypertension, angiotensin II type 1 receptor blocker, olmesartan
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 144 participants (actual)
Lead sponsor: Daiichi SankyoIndustry (pharma, biotech, devices)
Study start: Aug 2006
Primary completion: Jun 2007 (actual)
Study completion: Aug 2007 (actual)
First posted: 30 Apr 2009 (estimated)
Results: Posted 30 Apr 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment	Experimental	Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary

Who may qualify

Ages: 30 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Stage 1 and 2 hypertension without treatment for at least 2 weeks
Women with no risk of becoming pregnant

Key exclusion criteria (11 listed)

Study participation could result in risk to health of subject
Cardiovascular disease
Secondary hypertension or stage 3 hypertension
Myocardial infarction within the last 6 months
Congestive heart failure

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessaryolmesartan medoxomil tablets,or olmesartan medoxomil/hydrochlorothiazide tablets, if necessary + amlodipine tablets, if necessary. All interventions are once-daily for 4 to 9 weeks	Drug	Treatment

Primary outcome

Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 (Olmesartan 20 mg Monotherapy)
Time frame: 4 - 9 wks of olmesartan monotherapy
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
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)
Time frame: 4 to 9 weeks on combination therapy
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
Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Second Titrated Group (Olmesartan 40 mg + 25 mg Hydrochlorothiazide)
Time frame: 4 to 9 weeks
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.
Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Third Titrated Group (Olmesartan + Hydrochorothiazide + Amlodipine)
Time frame: 4 - 9 weeks
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.

Results and safety

Results posted to the registry on 30 Apr 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Olmesartan + Hydrochlorothiazide + Amlodipine	144	124

Primary outcome: Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 (Olmesartan 20 mg Monotherapy)

Time frame: 4 - 9 wks of olmesartan monotherapy. Number. Unit: Participants

Measure	Olmesartan Monotherapy n = 144
Value	38

Population analysed: 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.

Primary outcome: 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)

Time frame: 4 to 9 weeks on combination therapy. Number. Unit: Participants

Measure	Olmesartan + Hydrochlorothiazide n = 106
Value	33

Population analysed: 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.

Primary outcome: Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Second Titrated Group (Olmesartan 40 mg + 25 mg Hydrochlorothiazide)

Time frame: 4 to 9 weeks. Number. Unit: Participants

Measure	Olmesartan + Hydrochlorothiazide n = 73
Value	41

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

Primary outcome: Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Third Titrated Group (Olmesartan + Hydrochorothiazide + Amlodipine)

Time frame: 4 - 9 weeks. Number. Unit: Participants

Measure	Olmesartan + Hydrochlorothiazide + Amlodipine n = 32
Value	12

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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Essential Hypertension

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Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
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Recruiting
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Not yet recruitingObservational study
A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary in people with Essential Hypertension, run by Daiichi Sankyo.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 (Olmesartan 20 mg Monotherapy) (time frame: 4 - 9 wks of olmesartan monotherapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00890591.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2009.