HypertensionPhase 4NCT00430638

A Study of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Stage I and Stage II Hypertension

A Phase 4 study testing olmesartan medoxomil + hydrochlorothiazide, if necessary in people with Hypertension, run by Daiichi Sankyo at 29 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 16 week study will examine the ability of olmesartan medoxomil to lower the blood pressure of patients with moderate to severe high blood pressure in comparison to placebo. The medication being tested has been approved by the FDA for the treatment of high blood pressure. 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 + hydrochlorothiazide, if necessary
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 278 participants
Where: 29 sitesUnited States
Study dates: Dec 2006to Oct 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Greater than or equal to 18 years of age.
Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to 140 mmHg but less than or equal to 179 mmHg and a mean seated diastolic blood pressure (MSDBP) less than or equal to 109 mmHg following a 3 to 4-week single-blind placebo run-in period.
The difference in MSSBP between Visits 3 and 4 or between Visits 4 and 4X must be less than or equal to 10 mmHg.
Patients with a mean daytime (8AM-4PM) systolic blood pressure (SBP) greater than or equal to 135 mmHg and less than or equal to 179 mmHg and a mean daytime diastolic blood pressure (DBP) less than or equal to 109 mmHg as measured by an ambulatory blood pressure monitoring device (ABPM) following placebo run-in period.
If female, must have negative serum pregnancy test at screening and be either post-menopausal (greater than or equal to 1 year), had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study.

Who cannot join

History of stroke or transient ischemic attack (TIA) within the last one year.
History of myocardial infarction, coronary angioplasty, coronary artery bypass graft, or heart failure within the past 6 months.
Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or Cushing's syndrome.
Type I diabetes. Patients with Type II diabetes on stable treatment, with fasting glucose <160 mg/dl may enroll.
Patients with hemodynamically significant cardiac valvular disease.
Patients with clinically significant cardiac conduction defects, including first, second or third degree 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

29 sites in 1 country.

City, postcode or hospital

29 sites in 1 country

United States29 sites

Study site
Birmingham, Alabama
Study site
Carmichael, California
Study site
Charleston, South Carolina
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Colleyville, Texas
Study site
Coral Gables, Florida
Study site
Deerfield Beach, Florida
Study site
DeLand, Florida
Study site
Downingtown, Pennsylvania
Study site
Elizabeth, New Jersey
Study site
Eugene, Oregon
Study site
Fort Lauderdale, Florida
Study site
Hialeah, Florida
Study site
Hollywood, Florida
Study site
Madison, Wisconsin
Study site
Manassas, Virginia
Study site
Mobile, Alabama
Study site
Murray, Utah
Study site
Muscle Shoals, Alabama
Study site
Nashville, Tennessee
Study site
New Tazewell, Tennessee
Study site
Oklahoma City, Oklahoma
Study site
Olympia, Washington
Study site
Pembroke Pines, Florida
Study site
San Antonio, Texas
Study site
Searcy, Arkansas
Study site
Spring Valley, California
Study site
Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: A Double-Blind, Randomized, Placebo Controlled, Parallel Group Study to Compare the Safety and Efficacy of an Olmesartan Medoxomil Based Treatment Regimen to Placebo in Patients With Stage I and Stage II Hypertension

Read the detailed description

This study was to randomize an equal number of participants to either an olmesartan medoxomil based treatment or to placebo. The titration scheme was as follows:

First 3 weeks (wks), all participants - olmesartan medoxomil 20 mg or placebo
Next 3 wks, participants whose blood pressure was not controlled - olmesartan medoxomil 40 mg or placebo
Next 3 wks, participants whose blood pressure was not controlled - olmesartan medoxomil 40 mg/HCT 12.5 mg or placebo
Final 3 wks, participants whose blood pressure was not controlled - olmesartan medoxomil 40 mg/HCT 25 mg or placebo
Subjects with a mean BP of <120/80 mmHg at any visit were considered responders and were not titrated up to the next dose level. However, they remained in the study at their currently assigned dose of study medication.
Subjects with a mean office SBP ≥120 mmHg or a mean office DBP ≥80 mmHg at any subsequent visit(s) were considered 'uncontrolled' and were titrated to the next dose level according to the titration scheme above.
Subjects who reach the highest dose (ie, olmesartan medoxomil 40 mg/HCT 25 mg) remained on that dose until study exit at Visit 8, unless safety concerns caused discontinuation of treatment.

Conditions: Hypertension
Being tested: olmesartan medoxomil + hydrochlorothiazide, if necessary, Placebo
Keywords: Hypertension, Angiotensin Receptor Blocker, Calcium Channel Blocker, Angiotensin Converting Enzyme Inhibitor, Hydrochlorothiazide, Stage I and II Hypertension
Medical subject headings: Hypertension

What participants receive

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

olmesartan medoxomil + hydrochlorothiazide, if necessaryDrug
olmesartan medoxomil + hydrochlorothiazide, if necessary. Oral tablets administered for once daily for 12 weeks
PlaceboDrug
Oral tablets administered for once daily for 12 weeks

Study groups in NCT00430638
Study group	Role	What they receive
Treatment	Experimental	Olmesartan medoxomil, plus hydrochlorothiazide, if necessary Receives: Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary
Placebo	Placebo comparator	Placebo tablets were taken once daily for 12 weeks Receives: Drug: Placebo

What is being measured

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

Change From Baseline in Mean Systolic Blood Pressure (SBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device.
The change from baseline in mean systolic blood pressure (SBP) after 12 weeks of randomized treatment was compared between the olmesartan based treatment group and the placebo treatment group.
Measured: baseline to 12 weeks

Secondary outcomes (9)

Change From Baseline in Mean Diastolic Blood Pressure (DBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device.
Change from study baseline (average of triplicate DBP measurements at the last 2 qualifying visits during placebo run-in period) in DBP to the end of 12 weeks of randomized treatment using a last observation carried forward (LOCF) approach.
Measured: baseline to 12 weeks
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Males.
The difference in the change from baseline to week 12 in seated systolic and diastolic blood pressure for males in the olmesartan group vs. the placebo group was analyzed.
Measured: Baseline to week 12
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Females.
The difference in the change from baseline to week 12 in seated blood pressure for females in the olmesartan group vs. the placebo group was analyzed.
Measured: Baseline to week 12
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Less Than 65 Years Old.
Measured: Baseline to 12 weeks
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Greater Than or Equal to 65 Years Old.
Measured: Baseline to 12 weeks
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Black Participants.
Measured: Baseline to week 12
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Non-Black Participants.
Measured: Baseline to 12 weeks
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Stage 1 Hypertensives
Measured: Baseline to 12 weeks
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Stage 2 Hypertensives
Measured: Baseline to 12 months

Timeline

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

Dec 2006Oct 2007

First posted2 Feb 2007 (estimated)
Study startDec 2006
Primary completionOct 2007
Study completionOct 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.
Publications (2)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: 278 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00430638
Sponsor's protocol ID: 866-451
Status last verified: Sep 2018
First submitted: 1 Feb 2007
Last updated: 2 Oct 2018
Results posted: Yes, on ClinicalTrials.gov

Publications

Kereiakes DJ, Maa JF, Shojaee A, Dubiel R. Effect of an olmesartan medoxomil-based treatment algorithm on systolic blood pressure in patients with stage 1 or 2 hypertension: a randomized, double-blind, placebo-controlled study. Am J Cardiovasc Drugs. 2010;10(4):239-46. doi: 10.2165/11538630-000000000-00000.
PubMed 20653330
Oparil S, Chrysant SG, Kereiakes D, Xu J, Chavanu KJ, Waverczak W, Dubiel R. Results of an olmesartan medoxomil-based treatment regimen in hypertensive patients. J Clin Hypertens (Greenwich). 2008 Dec;10(12):911-21. doi: 10.1111/j.1751-7176.2008.00045.x.
PubMed 19120717

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?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Randomized, Placebo Controlled, Parallel Group Study to Compare the Safety and Efficacy of an Olmesartan Medoxomil Based Treatment Regimen to Placebo in Patients With Stage I and Stage II Hypertension
ClinicalTrials.gov ID: NCT00430638
Acronym / sponsor ID: 866-451
Conditions: Hypertension
Keywords: Hypertension, Angiotensin Receptor Blocker, Calcium Channel Blocker, Angiotensin Converting Enzyme Inhibitor, Hydrochlorothiazide, Stage I and II Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 278 participants (actual)
Lead sponsor: Daiichi SankyoIndustry (pharma, biotech, devices)
Study start: Dec 2006
Primary completion: Oct 2007 (actual)
Study completion: Oct 2007 (actual)
First posted: 2 Feb 2007 (estimated)
Results: Posted 22 Jan 2010

Clinical summary

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

Detailed description

This study was to randomize an equal number of participants to either an olmesartan medoxomil based treatment or to placebo. The titration scheme was as follows:

First 3 weeks (wks), all participants - olmesartan medoxomil 20 mg or placebo
Next 3 wks, participants whose blood pressure was not controlled - olmesartan medoxomil 40 mg or placebo
Next 3 wks, participants whose blood pressure was not controlled - olmesartan medoxomil 40 mg/HCT 12.5 mg or placebo
Final 3 wks, participants whose blood pressure was not controlled - olmesartan medoxomil 40 mg/HCT 25 mg or placebo
Subjects with a mean BP of <120/80 mmHg at any visit were considered responders and were not titrated up to the next dose level. However, they remained in the study at their currently assigned dose of study medication.
Subjects with a mean office SBP ≥120 mmHg or a mean office DBP ≥80 mmHg at any subsequent visit(s) were considered 'uncontrolled' and were titrated to the next dose level according to the titration scheme above.
Subjects who reach the highest dose (ie, olmesartan medoxomil 40 mg/HCT 25 mg) remained on that dose until study exit at Visit 8, unless safety concerns caused discontinuation of treatment.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Treatment	Experimental	Drug: olmesartan medoxomil + hydrochlorothiazide, if necessaryOlmesartan medoxomil, plus hydrochlorothiazide, if necessary
Placebo	Placebo comparator	Drug: PlaceboPlacebo tablets were taken once daily for 12 weeks

Who may qualify

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

Key inclusion criteria (5 listed)

Greater than or equal to 18 years of age.
Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to 140 mmHg but less than or equal to 179 mmHg and a mean seated diastolic blood pressure (MSDBP) less than or equal to 109 mmHg following a 3 to 4-week single-blind placebo run-in period.
The difference in MSSBP between Visits 3 and 4 or between Visits 4 and 4X must be less than or equal to 10 mmHg.
Patients with a mean daytime (8AM-4PM) systolic blood pressure (SBP) greater than or equal to 135 mmHg and less than or equal to 179 mmHg and a mean daytime diastolic blood pressure (DBP) less than or equal to 109 mmHg as measured by an ambulatory blood pressure monitoring device (ABPM) following placebo run-in period.
If female, must have negative serum pregnancy test at screening and be either post-menopausal (greater than or equal to 1 year), had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study.

Key exclusion criteria (6 listed)

History of stroke or transient ischemic attack (TIA) within the last one year.
History of myocardial infarction, coronary angioplasty, coronary artery bypass graft, or heart failure within the past 6 months.
Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or Cushing's syndrome.
Type I diabetes. Patients with Type II diabetes on stable treatment, with fasting glucose <160 mg/dl may enroll.
Patients with hemodynamically significant cardiac valvular disease.

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 necessaryolmesartan medoxomil + hydrochlorothiazide, if necessary. Oral tablets administered for once daily for 12 weeks	Drug	Treatment
PlaceboOral tablets administered for once daily for 12 weeks	Drug	Placebo

Primary outcome

Change From Baseline in Mean Systolic Blood Pressure (SBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device.
Time frame: baseline to 12 weeks
The change from baseline in mean systolic blood pressure (SBP) after 12 weeks of randomized treatment was compared between the olmesartan based treatment group and the placebo treatment group.

9 secondary outcomes

Change From Baseline in Mean Diastolic Blood Pressure (DBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device.
Time frame: baseline to 12 weeks
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Males.
Time frame: Baseline to week 12
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Females.
Time frame: Baseline to week 12
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Less Than 65 Years Old.
Time frame: Baseline to 12 weeks
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Greater Than or Equal to 65 Years Old.
Time frame: Baseline to 12 weeks
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Black Participants.
Time frame: Baseline to week 12
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Non-Black Participants.
Time frame: Baseline to 12 weeks
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Stage 1 Hypertensives
Time frame: Baseline to 12 weeks
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Stage 2 Hypertensives
Time frame: Baseline to 12 months

Results and safety

Results posted to the registry on 22 Jan 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo (Pbo) Group	138	60
Olmesartan Group	140	92

Primary outcome: Change From Baseline in Mean Systolic Blood Pressure (SBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device.

Time frame: baseline to 12 weeks. Least squares mean (Standard Error). Unit: mm Hg

Measure	Placebo n = 137	Olmesartan Group n = 139
Value	-0.1 (1.40)	-22.3 (1.39)

Placebo vs Olmesartan Group: p <0.0001, ANCOVA

Population analysed: The efficacy cohort is defined as any subject who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline efficacy blood pressure assessment. 140 participants were originally randomized to the olmesartan group. 139 is the correct number analyzed. For the placebo group the efficacy cohort = 137.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12-week randomized, treatment period plus 30 days after the last dose of study medication.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (Pbo) Group	0 of 138 (0%)	46 of 138 (33.3%)	Not reported
Olmesartan Group	3 of 140 (2.1%)	55 of 140 (39.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20653330Kereiakes DJ, Maa JF, Shojaee A, Dubiel R. Effect of an olmesartan medoxomil-based treatment algorithm on systolic blood pressure in patients with stage 1 or 2 hypertension: a randomized, double-blind, placebo-controlled study. Am J Cardiovasc Drugs. 2010;10(4):239-46. doi: 10.2165/11538630-000000000-00000.
Results publication: PubMed 19120717Oparil S, Chrysant SG, Kereiakes D, Xu J, Chavanu KJ, Waverczak W, Dubiel R. Results of an olmesartan medoxomil-based treatment regimen in hypertensive patients. J Clin Hypertens (Greenwich). 2008 Dec;10(12):911-21. doi: 10.1111/j.1751-7176.2008.00045.x.

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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.

29 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 + hydrochlorothiazide, if necessary in people with Hypertension, run by Daiichi Sankyo at 29 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 5 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 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 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 22 Jan 2010). 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 in Mean Systolic Blood Pressure (SBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device. (time frame: baseline to 12 weeks). 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 NCT00430638, which also lists 2 linked publications.

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 2 Oct 2018.