HypertensionPhase 4NCT00949884

Olmesartan Comparison to Losartan in Hypertensive Subjects

A Phase 4 study testing olmesartan medoxomil and losartan potassium in people with Hypertension, run by Daiichi Sankyo at 20 sites in United States.

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

This study will evaluate the efficacy and safety of the FDA approved blood pressure medication olmesartan medoxomil compared to the FDA approved medication losartan potassium. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension
What is being tested?: olmesartan medoxomil and losartan potassium
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 941 participants
Where: 20 sitesUnited States
Study dates: Aug 2009to Jan 2010
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males or females aged > 18 years who are not institutionalized and have signed informed consent.
Mean cuff seated diastolic blood pressure (BP) must be > 95 mmHg and < 115 mmHg and a mean cuff seated systolic BP must be < 180 mmHg when measured at two consecutive qualification study visits during the placebo run-in phase.
The difference in mean cuff seated diastolic BP must be < 7 mmHg between two consecutive qualification study visits during the placebo run-in phase.

Who cannot join

Subjects with type 2 diabetes mellitus with an HbA1c ≥ 9.5% at Screening.
Subjects with serious disorders which may limit the ability to evaluate the efficacy or safety of olmesartan medoxomil and losartan potassium, including cardiovascular, renal (including the absence of one kidney), pulmonary, hepatic, gastrointestinal (including clinically significant malabsorption), endocrine/metabolic (with the exception of non-insulin, dependent type 2 diabetes mellitus with HbA1c < 9.5% at Screening), hematologic/oncologic (including an active malignancy other than basal cell carcinoma), neurologic and psychiatric diseases.
Subjects with a history of myocardial infarction, angina, coronary angioplasty, bypass surgery or heart failure within the last 12 months.
Subjects with any history of New York Heart Association Class III or IV congestive heart failure (CHF). A history of New York Heart Association Class I or II CHF may be exclusionary at the discretion of the Investigator.
Subjects with a history of cerebrovascular accident or transient ischemic attack within the last 1 year.
Subjects with clinically significant cardiac conduction defects, including second or third degree atrioventricular (AV) block, left bundle branch block, sick sinus syndrome, atrial fibrillation, atrial flutter, an accessory bypass tract, or any arrhythmia requiring medication.

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

Study site
Albuquerque, New Mexico, 87108
Study site
Binghamton, New York, 13701
Study site
Bristol, Tennessee, 37620
Study site
Charlotte, North Carolina, 28209
Study site
Cincinnati, Ohio, 45219
Study site
Dallas, Texas, 75230
Study site
Deerfield Beach, Florida, 33442
Study site
DeLand, Florida, 32720
Study site
Greenville, South Carolina, 29615
Study site
Harbor City, California, 90710
Study site
Mesa, Arizona, 85213
Study site
Metairie, Louisiana, 70006
Study site
New Tazewell, Tennessee, 37825
Study site
Norfolk, Virginia, 23502
Study site
Phoenix, Arizona, 85050
Study site
Pueblo, Colorado, 81001
Study site
South Bend, Indiana, 46614
Study site
Tustin, California, 92780
Study site
Westlake Village, California, 91361
Study site
Wichita, Kansas, 67205

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Active-comparator, 8-week Forced-titration Study of the Efficacy and Safety of Olmesartan Medoxomil Versus Losartan Potassium in Hypertensive Subjects

This study will evaluate the efficacy and safety of the FDA approved blood pressure medication olmesartan medoxomil compared to the FDA approved medication losartan potassium.

Conditions: Hypertension
Being tested: olmesartan medoxomil, Placebo, losartan potassium
Medical subject headings: Hypertension

What participants receive

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

olmesartan medoxomilDrug
Also called Benicar, Olmetec
Oral tablets, once daily, at either 20mg or 40mg daily.
PlaceboDrug
placebo oral tablets once daily for two weeks
losartan potassiumDrug
Also called Cozaar
losartan potassium oral tablet at either 50mg or 100 mg daily dose.

Study groups in NCT00949884
Study group	Role	What they receive
Olmesartan	Experimental	Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks. Receives: Drug: olmesartan medoxomil
Placebo followed by Olmesartan	Placebo comparator	Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks Receives: Drug: olmesartan medoxomil; Drug: Placebo
Losartan	Active comparator	Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks Receives: Drug: losartan potassium

What is being measured

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

Change From Baseline to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)
The change from baseline in trough SDBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.
Measured: Day 0, Week 8

Secondary outcomes (3)

Change From Baseline to Week 4 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)
The change from baseline in trough SSBP at Week 4 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.
Measured: Day 0, Week 4
Change From Baseline to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)
The change from baseline in trough SSBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.
Measured: Day 0, Week 8
Change From Baseline to Week 4 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)
The change from baseline in trough SDBP at Week 4 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.
Measured: Day 0, Week 4

Timeline

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

Aug 2009Jan 2010

First posted30 Jul 2009 (estimated)
Study startAug 2009
Primary completionJan 2010
Study completionJan 2010

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for 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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 941 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00949884
Sponsor's protocol ID: CS0866-A-U452
Status last verified: Mar 2011
First submitted: 29 Jul 2009
Last updated: 9 Mar 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Punzi HA, Lewin A, Li W, Chavanu KJ. Efficacy/safety of olmesartan medoxomil versus losartan potassium in naive versus previously treated subjects with hypertension. Adv Ther. 2012 Jun;29(6):524-37. doi: 10.1007/s12325-012-0029-5. Epub 2012 Jul 3.
PubMed 22763801

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?

See locations

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Active-comparator, 8-week Forced-titration Study of the Efficacy and Safety of Olmesartan Medoxomil Versus Losartan Potassium in Hypertensive Subjects
ClinicalTrials.gov ID: NCT00949884
Acronym / sponsor ID: CS0866-A-U452
Conditions: Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 941 participants (actual)
Lead sponsor: Daiichi SankyoIndustry (pharma, biotech, devices)
Study start: Aug 2009
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 30 Jul 2009 (estimated)
Results: Posted 28 Feb 2011

Clinical summary

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

This study will evaluate the efficacy and safety of the FDA approved blood pressure medication olmesartan medoxomil compared to the FDA approved medication losartan potassium.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Olmesartan	Experimental	Drug: olmesartan medoxomilOlmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
Placebo followed by Olmesartan	Placebo comparator	Drug: olmesartan medoxomil, Drug: PlaceboPlacebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks
Losartan	Active comparator	Drug: losartan potassiumLosartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Males or females aged > 18 years who are not institutionalized and have signed informed consent.
Mean cuff seated diastolic blood pressure (BP) must be > 95 mmHg and < 115 mmHg and a mean cuff seated systolic BP must be < 180 mmHg when measured at two consecutive qualification study visits during the placebo run-in phase.
The difference in mean cuff seated diastolic BP must be < 7 mmHg between two consecutive qualification study visits during the placebo run-in phase.

Key exclusion criteria (6 listed)

Subjects with type 2 diabetes mellitus with an HbA1c ≥ 9.5% at Screening.
Subjects with serious disorders which may limit the ability to evaluate the efficacy or safety of olmesartan medoxomil and losartan potassium, including cardiovascular, renal (including the absence of one kidney), pulmonary, hepatic, gastrointestinal (including clinically significant malabsorption), endocrine/metabolic (with the exception of non-insulin, dependent type 2 diabetes mellitus with HbA1c < 9.5% at Screening), hematologic/oncologic (including an active malignancy other than basal cell carcinoma), neurologic and psychiatric diseases.
Subjects with a history of myocardial infarction, angina, coronary angioplasty, bypass surgery or heart failure within the last 12 months.
Subjects with any history of New York Heart Association Class III or IV congestive heart failure (CHF). A history of New York Heart Association Class I or II CHF may be exclusionary at the discretion of the Investigator.
Subjects with a history of cerebrovascular accident or transient ischemic attack within the last 1 year.

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 medoxomilAlso: Benicar, OlmetecOral tablets, once daily, at either 20mg or 40mg daily.	Drug	Olmesartan, Placebo followed by Olmesartan
Placeboplacebo oral tablets once daily for two weeks	Drug	Placebo followed by Olmesartan
losartan potassiumAlso: Cozaarlosartan potassium oral tablet at either 50mg or 100 mg daily dose.	Drug	Losartan

Primary outcome

Change From Baseline to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)
Time frame: Day 0, Week 8
The change from baseline in trough SDBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.

3 secondary outcomes

Change From Baseline to Week 4 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)
Time frame: Day 0, Week 4
Change From Baseline to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)
Time frame: Day 0, Week 8
Change From Baseline to Week 4 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)
Time frame: Day 0, Week 4

Results and safety

Results posted to the registry on 28 Feb 2011, 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	420	370
Placebo Followed by Olmesartan	52	37
Losartan	469	411

Primary outcome: Change From Baseline to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)

Time frame: Day 0, Week 8. Least squares mean (Standard Error). Unit: mmHg

Measure	Olmesartan n = 384	Combined Olmesartan n = 424	Losartan n = 426
Value	-9.8 (0.50)	-9.7 (0.45)	-7.1 (0.45)

Combined Olmesartan vs Losartan: Mean Difference (Final Values): -2.5 (95% CI -3.8 to -1.3), p <0.0001, ANCOVA

Population analysed: The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 to Week 8, or until the adverse event resolved or the condition stabilized.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Olmesartan	0 of 420 (0%)	133 of 420 (31.7%)	Not reported
Placebo Followed by Olmesartan	0 of 52 (0%)	21 of 52 (40.4%)	Not reported
Losartan	4 of 469 (0.9%)	148 of 469 (31.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22763801Punzi HA, Lewin A, Li W, Chavanu KJ. Efficacy/safety of olmesartan medoxomil versus losartan potassium in naive versus previously treated subjects with hypertension. Adv Ther. 2012 Jun;29(6):524-37. doi: 10.1007/s12325-012-0029-5. Epub 2012 Jul 3.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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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.

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing olmesartan medoxomil and losartan potassium in people with Hypertension, run by Daiichi Sankyo at 20 sites in United States.

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 3 inclusion and 6 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 9 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 28 Feb 2011). 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?

Change From Baseline to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP) (time frame: Day 0, Week 8). 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 NCT00949884, which also lists 1 linked publication.

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 9 Mar 2011.