HypertensionPhase 4NCT00403481

An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Patients With Type II Diabetes

A Phase 4 study testing olmesartan medoxomil and Olmesartan medoxomil plus Hydrochlorothiazide in people with Hypertension, run by Daiichi Sankyo at 27 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 examine the ability of olmesartan medoxomil to lower the blood pressure of patients with Type II diabetes and high blood pressure. 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 and Olmesartan medoxomil plus Hydrochlorothiazide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 192 participants
Where: 27 sitesUnited States
Study dates: Nov 2006to Dec 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

Patients diagnosed with Type II diabetes that are on stable treatment with hypoglycemic agents
Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to 140 mmHg but <200 mmHg and a MSDBP less than or equal to 114 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) SBP > 130 mmHg and less than or equal to 199 mmHg and a mean daytime DBP less than or equal to 114 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, 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, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months
Presence of overt proteinuria at screening
Severe hypertension (DBP greater than or equal to 115 mmHg or SBP greater than or equal to 200 mmHg)
Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or Cushing's syndrome
Type I or Type II diabetes requiring insulin
Evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease
Presence of heart block greater than first degree sinoatrial block, Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, Atrial fibrillation, or Atrial Flutter

Trial locations and contacts

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

United States27 sites

Study site
Auburn, Maine
Study site
Baltimore, Maryland
Study site
Birmingham, Alabama
Study site
Charlotte, North Carolina
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Colleyville, Texas
Study site
Corpus Christi, Texas
Study site
DeLand, Florida
Study site
Florissant, Missouri
Study site
Jackson, Mississippi
Study site
Los Angeles, California
Study site
Madisonville, Kentucky
Study site
Mesa, Arizona
Study site
Murray, Utah
Study site
New Talenwell, Tennessee
Study site
New Tazewell, Tennessee
Study site
Norfolk, Virginia
Study site
Oxon Hill, Maryland
Study site
Pembroke Pines, Florida
Study site
Richardson, Texas
Study site
Roseville, California
Study site
Searcy, Arkansas
Study site
Tustin, California
Study site
Wichita, Kansas
Study site
Williamsville, New York
Study site
Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: A Prospective, Open Label, Single Arm Study to Evaluate the Safety and Efficacy of an Olmesartan Medoxomil Based Treatment Regimen in Type II Diabetic Patients With Hypertension

Conditions: Hypertension
Being tested: olmesartan medoxomil, Olmesartan medoxomil plus Hydrochlorothiazide
Keywords: Hypertension, Angiotensin Receptor Blocker, Calcium Channel Blocker, Angiotensin Converting Enzyme Inhibitor, Hydrochlorothiazide, Stage I and II Hypertension, Type II Diabetes
Medical subject headings: Hypertension, Diabetes Mellitus, Type 2

What participants receive

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

olmesartan medoxomilDrug
Olmesartan medoxomil tablets, once daily
Olmesartan medoxomil plus HydrochlorothiazideDrug
Olmesartan medoxomil and hydrochlorothiazide combination tablets, once daily, if necessary

Study groups in NCT00403481
Study group	Role	What they receive
Active treatment	Experimental	Blood pressure (BP) measurements were taken every three weeks for 12 weeks. In accordance with their BP results, participants either stayed on their current medication or were started on the next higher regimen at the 3, 6, or 9 week visits. All participants began at 20 mg olmesartan, once daily for 3 weeks. The next higher regimen was olmesartan 40 mg, followed by olmesartan 40 mg + 12.5 mg hydrochlorothiazide, followed by olmesartan 40 mg + 25 mg of hydrochlorothiazide. Receives: Drug: olmesartan medoxomil; Drug: Olmesartan medoxomil plus Hydrochlorothiazide

What is being measured

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

Change From Baseline to Week 12 in Systolic BP (SBP) as Measured by 24-hour ABPM.
Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.
Measured: baseline and 12 weeks

Secondary outcomes (8)

Change From Baseline to Week 12 in Mean Daytime and Nighttime Ambulatory Blood Pressure Measurement (Systolic).
Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.
Measured: baseline and 12 weeks
Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 2 Hours of the Last (Week 12) 24-hour Dosing Period.
Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.
Measured: baseline and 12 weeks
Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 4 Hours of the Last (Week 12 ) 24-hour Dosing Period.
Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.
Measured: baseline and 12 weeks
Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 6 Hours of the Last (Week 12 ) 24-hour Dosing Period.
Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.
Measured: baseline and 12 weeks
Change From Baseline to Week 12 in Mean 24-hour Ambulatory BP (Diastolic)
Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.
Measured: baseline and 12 weeks
Change in Daytime and Nighttime Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12
Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.
Measured: baseline and 12 weeks
Change in Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12 During the Last 2 Hours of the Last (Week 12 ) 24-hour Dosing Period.
Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.
Measured: baseline and 12 Weeks
Change in Ambulatory BP (Diastolic) From Baseline to Week 12 During the Last (Week 12 ) 4 and 6 Hours of the Last 24-hour Dosing Period.
Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.
Measured: baseline and 12 weeks

Timeline

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

Nov 2006Dec 2007

First posted23 Nov 2006 (estimated)
Study startNov 2006
Primary completionNov 2007
Study completionDec 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 (3)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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 192 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00403481
Sponsor's protocol ID: 866-449
Status last verified: Sep 2016
First submitted: 22 Nov 2006
Last updated: 3 Nov 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Kereiakes DJ, Neutel JM. Seated cuff blood pressure-lowering efficacy of an olmesartan medoxomil-based treatment regimen in patients with type 2 diabetes mellitus. Drugs R D. 2011 Sep 1;11(3):251-7. doi: 10.2165/11592830-000000000-00000.
PubMed 21777013
Neutel JM, Kereiakes DJ; BENIFICIARY Investigators. An olmesartan medoxomil-based treatment algorithm is effective in achieving 24-hour BP control in patients with type 2 diabetes mellitus, regardless of age, race, sex, or severity of hypertension: subgroup analysis of the BENIFICIARY study. Am J Cardiovasc Drugs. 2010;10(5):289-303. doi: 10.2165/11584690-000000000-00000.
PubMed 20712386
Neutel JM, Kereiakes DJ, Waverczak WF, Stoakes KA, Xu J, Shojaee A. Effects of an olmesartan medoxomil based treatment algorithm on 24-hour blood pressure control in patients with hypertension and type 2 diabetes. Curr Med Res Opin. 2010 Mar;26(3):721-8. doi: 10.1185/03007990903553556.
PubMed 20085534

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 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Open Label, Single Arm Study to Evaluate the Safety and Efficacy of an Olmesartan Medoxomil Based Treatment Regimen in Type II Diabetic Patients With Hypertension
ClinicalTrials.gov ID: NCT00403481
Acronym / sponsor ID: 866-449
Conditions: Hypertension
Keywords: Hypertension, Angiotensin Receptor Blocker, Calcium Channel Blocker, Angiotensin Converting Enzyme Inhibitor, Hydrochlorothiazide, Stage I and II Hypertension, Type II Diabetes
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 192 participants (actual)
Lead sponsor: Daiichi SankyoIndustry (pharma, biotech, devices)
Study start: Nov 2006
Primary completion: Nov 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 23 Nov 2006 (estimated)
Results: Posted 15 Sep 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Active treatment	Experimental	Drug: olmesartan medoxomil, Drug: Olmesartan medoxomil plus HydrochlorothiazideBlood pressure (BP) measurements were taken every three weeks for 12 weeks. In accordance with their BP results, participants either stayed on their current medication or were started on the next higher regimen at the 3, 6, or 9 week visits. All participants began at 20 mg olmesartan, once daily for 3 weeks. The next higher regimen was olmesartan 40 mg, followed by olmesartan 40 mg + 12.5 mg hydrochlorothiazide, followed by olmesartan 40 mg + 25 mg of hydrochlorothiazide.

Who may qualify

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

Key inclusion criteria (5 listed)

Patients diagnosed with Type II diabetes that are on stable treatment with hypoglycemic agents
Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to 140 mmHg but <200 mmHg and a MSDBP less than or equal to 114 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) SBP > 130 mmHg and less than or equal to 199 mmHg and a mean daytime DBP less than or equal to 114 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, 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 (8 listed)

History of stroke or transient ischemic attack (TIA) within the last one year
History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months
Presence of overt proteinuria at screening
Severe hypertension (DBP greater than or equal to 115 mmHg or SBP greater than or equal to 200 mmHg)
Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or Cushing's syndrome

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 medoxomilOlmesartan medoxomil tablets, once daily	Drug	Active treatment
Olmesartan medoxomil plus HydrochlorothiazideOlmesartan medoxomil and hydrochlorothiazide combination tablets, once daily, if necessary	Drug	Active treatment

Primary outcome

Change From Baseline to Week 12 in Systolic BP (SBP) as Measured by 24-hour ABPM.
Time frame: baseline and 12 weeks
Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.

8 secondary outcomes

Change From Baseline to Week 12 in Mean Daytime and Nighttime Ambulatory Blood Pressure Measurement (Systolic).
Time frame: baseline and 12 weeks
Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 2 Hours of the Last (Week 12) 24-hour Dosing Period.
Time frame: baseline and 12 weeks
Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 4 Hours of the Last (Week 12 ) 24-hour Dosing Period.
Time frame: baseline and 12 weeks
Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 6 Hours of the Last (Week 12 ) 24-hour Dosing Period.
Time frame: baseline and 12 weeks
Change From Baseline to Week 12 in Mean 24-hour Ambulatory BP (Diastolic)
Time frame: baseline and 12 weeks
Change in Daytime and Nighttime Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12
Time frame: baseline and 12 weeks
Change in Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12 During the Last 2 Hours of the Last (Week 12 ) 24-hour Dosing Period.
Time frame: baseline and 12 Weeks
Change in Ambulatory BP (Diastolic) From Baseline to Week 12 During the Last (Week 12 ) 4 and 6 Hours of the Last 24-hour Dosing Period.
Time frame: baseline and 12 weeks

Results and safety

Results posted to the registry on 15 Sep 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
Active Treatment Period	192	186

Primary outcome: Change From Baseline to Week 12 in Systolic BP (SBP) as Measured by 24-hour ABPM.

Time frame: baseline and 12 weeks. Mean (Standard Error). Unit: mm Hg

Measure	Overall Study Population n = 172
Value	-20.4 (0.88)

Overall Study Population: p <0.0001, One-sample t-test

Population analysed: A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 week 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
Olmesartan 20 mg	0 of 192 (0%)	4 of 192 (2.1%)	Not reported
Olmesartan 40 mg	0 of 182 (0%)	5 of 182 (2.7%)	Not reported
Olmesartan 40 mg and Hydrochlorothiazide 12.5 mg	1 of 173 (0.6%)	3 of 173 (1.7%)	Not reported
Olmesartan 40 mg and Hydrochlorothiazide 25 mg	0 of 144 (0%)	6 of 144 (4.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21777013Kereiakes DJ, Neutel JM. Seated cuff blood pressure-lowering efficacy of an olmesartan medoxomil-based treatment regimen in patients with type 2 diabetes mellitus. Drugs R D. 2011 Sep 1;11(3):251-7. doi: 10.2165/11592830-000000000-00000.
Derived from this study: PubMed 20712386Neutel JM, Kereiakes DJ; BENIFICIARY Investigators. An olmesartan medoxomil-based treatment algorithm is effective in achieving 24-hour BP control in patients with type 2 diabetes mellitus, regardless of age, race, sex, or severity of hypertension: subgroup analysis of the BENIFICIARY study. Am J Cardiovasc Drugs. 2010;10(5):289-303. doi: 10.2165/11584690-000000000-00000.
Derived from this study: PubMed 20085534Neutel JM, Kereiakes DJ, Waverczak WF, Stoakes KA, Xu J, Shojaee A. Effects of an olmesartan medoxomil based treatment algorithm on 24-hour blood pressure control in patients with hypertension and type 2 diabetes. Curr Med Res Opin. 2010 Mar;26(3):721-8. doi: 10.1185/03007990903553556.

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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.

27 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 Olmesartan medoxomil plus Hydrochlorothiazide in people with Hypertension, run by Daiichi Sankyo at 27 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 8 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 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 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. 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 15 Sep 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?

Change From Baseline to Week 12 in Systolic BP (SBP) as Measured by 24-hour ABPM. (time frame: baseline and 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 NCT00403481, which also lists 3 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 3 Nov 2016.