CompletedNCT00403481Updated Nov 3, 2016Results posted

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

A Phase 4 interventional study of olmesartan medoxomil and Olmesartan medoxomil plus Hydrochlorothiazide in Hypertension, sponsored by Daiichi Sankyo. Completed at 27 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-03.

Sponsored by Daiichi Sankyo · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 192
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Hypertension

Browse trials for

Hypertension 6,689

Keywords

Hypertension
Angiotensin Receptor Blocker
Calcium Channel Blocker
Angiotensin Converting Enzyme Inhibitor
Hydrochlorothiazide
Stage I and II Hypertension
Type II Diabetes

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 192 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Daiichi Sankyo is the lead sponsor of 316 studies on the registry; 35 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 38 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 192 participants (actual)

Study arms

Experimental
Active treatment
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.
Drug: olmesartan medoxomil · Drug: Olmesartan medoxomil plus Hydrochlorothiazide

Interventions

Drugolmesartan medoxomil
Olmesartan medoxomil tablets, once daily
DrugOlmesartan medoxomil plus Hydrochlorothiazide
Olmesartan medoxomil and hydrochlorothiazide combination tablets, once daily, if necessary

What researchers measure

Primary outcomes

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.
Time frame: baseline and 12 weeks

Secondary outcomes

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.
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.
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.
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.
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.
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.
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.
Time frame: 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.
Time frame: 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.
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.
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.
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.
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.
Time frame: baseline and 12 weeks

Results

Posted Sep 15, 2009

Participant flow

Subjects were recruited at 24 US sites over 10 months from November 2006 to August 2007 from each physician's clientele base. Approximately 200 eligible subjects, men and women at least 18 years of age with stage I/II hypertension and stable type 2 diabetes mellitus, were to be enrolled on active treatment.

Olmesartan Medoxomil (Olm) 20 mg

Participant flow — Olmesartan Medoxomil (Olm) 20 mg
Milestone	Active Treatment Period
Started	192
Completed	186
Not completed	6
Withdrew: Adverse event	1
Withdrew: Physician decision	1
Withdrew: Protocol violation	3
Withdrew: Withdrawal by subject	1

Olm 40 mg

Participant flow — Olm 40 mg
Milestone	Active Treatment Period
Started	182
Completed	177
Not completed	5
Withdrew: Adverse event	2
Withdrew: Protocol violation	1
Withdrew: Withdrawal by subject	1
Withdrew: Other	1

Olm 40 mg + Hydrochlorothiazide 12.5 mg

Participant flow — Olm 40 mg + Hydrochlorothiazide 12.5 mg
Milestone	Active Treatment Period
Started	173
Completed	168
Not completed	5
Withdrew: Adverse event	2
Withdrew: Protocol violation	1
Withdrew: Withdrawal by subject	1
Withdrew: Other	1

Olm 40 mg + Hydrochlorothiazide 25 mg

Participant flow — Olm 40 mg + Hydrochlorothiazide 25 mg
Milestone	Active Treatment Period
Started	144
Completed	142
Not completed	2
Withdrew: Withdrawal by subject	1
Withdrew: Lost to follow-up	1

Outcome measures

PrimaryChange 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.

Time frame:: baseline and 12 weeks
Reported as:: Mean · mm Hg

Change From Baseline to Week 12 in Systolic BP (SBP) as Measured by 24-hour ABPM.
mm Hg	Overall Study Population
Change From Baseline to Week 12 in Systolic BP (SBP) as Measured by 24-hour ABPM.	-20.4 ± 0.88

Statistical analysis

Overall Study Population · One-sample t-test · p = <0.0001 (No multiplicity adjustments)

SecondaryChange From Baseline to Week 12 in Mean Daytime and Nighttime Ambulatory Blood Pressure Measurement (Systolic).

Time frame:: baseline and 12 weeks
Reported as:: Mean · mm Hg

Change From Baseline to Week 12 in Mean Daytime and Nighttime Ambulatory Blood Pressure Measurement (Systolic).
mm Hg	Overall Study Population
Daytime	-22.3 ± 1.05
Nighttime	-18.8 ± 0.94

Statistical analysis

Overall Study Population · one-sample t-test · p = <0.0001 (\<0.0001 for both daytime and nighttime. No multiplicity adjustments.)

SecondaryChange 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
Reported as:: Mean · mm Hg

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.
mm Hg	Overall Study Population
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.	-18.6 ± 1.11

Statistical analysis

Overall Study Population · One-sample t-test · p = <0.0001

SecondaryChange 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
Reported as:: Mean · mm Hg

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.
mm Hg	Overall Study Population
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.	-18.2 ± 1.00

Statistical analysis

Overall Study Population · one-sample t-test · p = 0.0001 (No multiplicity adjustments)

SecondaryChange 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
Reported as:: Mean · mm Hg

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.
mm Hg	Overall Study Population
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.	-18.6 ± 0.92

SecondaryChange From Baseline to Week 12 in Mean 24-hour Ambulatory BP (Diastolic)

Time frame:: baseline and 12 weeks
Reported as:: Mean · mm Hg

Change From Baseline to Week 12 in Mean 24-hour Ambulatory BP (Diastolic)
mm Hg	Overall Study Population
Change From Baseline to Week 12 in Mean 24-hour Ambulatory BP (Diastolic)	-11.1 ± 0.54

Statistical analysis

Overall Study Population · one-sample t-test · p = <0.0001

SecondaryChange in Daytime and Nighttime Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12

Time frame:: baseline and 12 weeks
Reported as:: Mean · mm Hg

Change in Daytime and Nighttime Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12
mm Hg	Overall Study Population
Daytime	-12.0 ± 0.68
Nighttime	-10.2 ± 0.55

Statistical analysis

Overall Study Population · one-sample t-test · p = <0.0001 (\<0.0001 applies to both the daytime and nighttime analyses)

SecondaryChange 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
Reported as:: Mean · mm Hg

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.
mm Hg	Overall Study Population
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.	-10.6 ± 0.78

Statistical analysis

Overall Study Population · one-sample t-test · p = <0.0001

SecondaryChange 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
Reported as:: Mean · mm Hg

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.
mm Hg	Overall Study Population
4 hours	-10.7 ± 0.66
6 hours	-10.8 ± 0.61

Statistical analysis

Overall Study Population · one-sample t-test · p = <0.0001 (\<0.0001 applies to both 4 hour and 6 hour analyses)

Adverse events

Collected over 12 week treatment period plus 30 days after the last dose of study medication.. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Olmesartan 20 mg	—	0/192 (0%)	4/192 (2.1%)
Olmesartan 40 mg	—	0/182 (0%)	5/182 (2.7%)
Olmesartan 40 mg and Hydrochlorothiazide 12.5 mg	—	1/173 (0.6%)	3/173 (1.7%)
Olmesartan 40 mg and Hydrochlorothiazide 25 mg	—	0/144 (0%)	6/144 (4.2%)

Most frequent serious events

Most frequent serious events
Event	Olmesartan 20 mg	Olmesartan 40 mg	Olmesartan 40 mg and Hydrochlorothiazide 12.5 mg	Olmesartan 40 mg and Hydrochlorothiazide 25 mg
Death due to arteriosclerotic cardiovascular diseaseGeneral disorders	0/192	0/182	1/173	0/144

Most frequent other events

Most frequent other events
Event	Olmesartan 20 mg	Olmesartan 40 mg	Olmesartan 40 mg and Hydrochlorothiazide 12.5 mg	Olmesartan 40 mg and Hydrochlorothiazide 25 mg
ArthralgiaMusculoskeletal and connective tissue disorders	1/192	2/182	2/173	3/144
Pain in extremityMusculoskeletal and connective tissue disorders	0/192	0/182	1/173	3/144
BronchitisInfections and infestations	3/192	3/182	0/173	0/144

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Active Treatmant Arm
Mean	58.1 ± 10.3

Sex: Female, Male
Sex: Female, Male(Participants)	Active Treatmant Arm
Female	85
Male	107

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Active Treatmant Arm
Black/African American	43
Asian	3
White	145
Native Hawaiian/Pacific Islander	1

Region of Enrollment
Region of Enrollment(participants)	Active Treatmant Arm
United States	192

Diastolic BP
Diastolic BP(mm Hg)	Active Treatmant Arm
Mean	90.0 ± 10.0

Heart rate
Heart rate(beats/min)	Active Treatmant Arm
Mean	76.4 ± 10.4

Systolic BP
Systolic BP(mm Hg)	Active Treatmant Arm
Mean	158.1 ± 12.6

Study locations

27 sites

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

References and documents

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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 3, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00403481
Lead sponsor: Daiichi Sankyo
First posted: Nov 23, 2006
Start date: Nov 2006
Primary completion: Nov 2007
Completion: Dec 2007
Results posted: Sep 15, 2009
Last update: Nov 3, 2016

View the source record on ClinicalTrials.gov ↗

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

Study summary

Conditions studied

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Keywords

In context

Hypertension

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Updates

Registry details

Key details

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria