An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Elderly Patients With Hypertension (NCT00412932)

01

Study summary

This 14 week study will examine the ability of olmesartan medoxomil to lower the blood pressure of patients 65 years of age or older with high blood pressure. The medication being tested has been approved by the FDA for the treatment of high blood pressure.

02

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

03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 964 are open to participants now.

This study's enrollment of 178 is above the median of 90 across 4,994 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.

04

Who can participate

Ages eligible: 65 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Males or Females greater than 65 years of age
Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to 150 mmHg but less than 200 mm Hg and a mean seated diastolic blood pressure (MSDBP) less than or equal to 109 mmHg following a 2-3 week single blind placebo run-in period.
The difference in MSSBP between visits 2 and 3 or between visits 3 and 3x 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 140 mmHg and less than or equal to 199 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.

Exclusion criteria

Exclusion Criteria:

History of stroke or transient ischemic attack (TIA) within the last one year.
History of myocardial infarction, angina, coronary angioplasty, coronary artery bypass graft, or heart failure within the past 6 months.
Severe hypertension (diastolic blood pressure greater than 115 mmHg or systolic blood pressure 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 diabetes or Type II diabetics not on stable treatment for greater than or equal to 4 weeks and plasma glucose greater than 160 mg/dl.
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, an accessory bypass tract, atrial fibrillation, atrial flutter or any arrhythmia requiring medication.
Serum Creatinine greater than 1.7 mg/dl, or other abnormal laboratory values deemed clinically significant by the investigator.

05

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 178 participants (actual)

Interventions

DrugOlmesartan medoxomil
Tablets
DrugOlmesartan medoxomil/hydrochlorothiazide
Tablets

06

What researchers measure

Primary outcomes

Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment
All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.
Time frame: baseline to 12 weeks

Secondary outcomes

Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure After 12 Weeks of Active Treatment.
All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.
Time frame: baseline to 12 weeks
Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10pm-6am)Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment
All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.
Time frame: baseline to 12 weeks
Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10 Pm-6am) Ambulatory Blood Pressure Monitored Diastolic Blood Pressure After 12 Weeks of Active Treatment
All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.
Time frame: baseline to 12 weeks
Number of Subjects Who Achieved Mean 24-hour Ambluatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment
All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.
Time frame: baseline to 12 weeks
Number of Subjects Who Achieved Mean Daytime (8am - 4pm) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment.
All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.
Time frame: baseline to 12 weeks
Number of Subjects Who Achieved Mean Nighttime (10pm - 6am) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment.
All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.
Time frame: baseline to 12 weeks

07

Results

Posted Sep 11, 2009

Participant flow

Participants were recruited at 37 US sites (private medical practices and small clinics) over 13 months (Nov 29,06 to Dec 28,07) from each physician's clientele base. Approximately 200 eligible participants, men and women at least 65 years of age with hypertension or uncontrolled hypertension on current medication, were to receive active treatment

Olmesartan (Olm) 20 mg

Participant flow — Olmesartan (Olm) 20 mg
Milestone	Active Treatment Period
Started	178
Completed	171
Not completed	7
Withdrew: Adverse event	1
Withdrew: Lack of efficacy	2
Withdrew: Protocol violation	1
Withdrew: Withdrawal by subject	2
Withdrew: Other	1

Olmesartan 40 mg

Participant flow — Olmesartan 40 mg
Milestone	Active Treatment Period
Started	169
Completed	161
Not completed	8
Withdrew: Adverse event	4
Withdrew: Lack of efficacy	3
Withdrew: Withdrawal by subject	1

Olm+Hydrochlorothiazide 12.5 mg

Participant flow — Olm+Hydrochlorothiazide 12.5 mg
Milestone	Active Treatment Period
Started	159
Completed	153
Not completed	6
Withdrew: Adverse event	3
Withdrew: Withdrawal by subject	3

Olm+ Hydrochlorothiazide 25 mg

Participant flow — Olm+ Hydrochlorothiazide 25 mg
Milestone	Active Treatment Period
Started	125
Completed	123
Not completed	2
Withdrew: Adverse event	1
Withdrew: Lost to follow-up	1

Outcome measures

PrimaryChange From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment

All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.

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

Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment
mm Hg	Overall Study
Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment	-25.7 ± 0.96

Statistical analysis

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

SecondaryChange From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure After 12 Weeks of Active Treatment.

All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.

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

Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure After 12 Weeks of Active Treatment.
mm Hg	Overall Study
Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure After 12 Weeks of Active Treatment.	-12.3 ± 0.55

Statistical analysis

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

SecondaryChange From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10pm-6am)Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment

All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.

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

Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10pm-6am)Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment
mm Hg	Overall Study
Daytime	-26.5 ± 1.10
Nighttime	-24.4 ± 1.04

Statistical analysis

Overall Study · one-sample t-test · p = <0.0001 (No multiplicity adjustments. This P-Value applies to both the daytime and nighttime periods.)

SecondaryChange From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10 Pm-6am) Ambulatory Blood Pressure Monitored Diastolic Blood Pressure After 12 Weeks of Active Treatment

All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.

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

Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10 Pm-6am) Ambulatory Blood Pressure Monitored Diastolic Blood Pressure After 12 Weeks of Active Treatment
mm Hg	Overall Study
Daytime	-13.0 ± 0.65
Nighttime	-11.5 ± 0.60

Statistical analysis

Overall Study · one-sample t-test · p = <0.0001 (No multiplicity adjustments. The P-Value of \<0.0001 applies to both daytime and nighttime periods.)

SecondaryNumber of Subjects Who Achieved Mean 24-hour Ambluatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment

All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.

Time frame:: baseline to 12 weeks
Reported as:: Number · participants

Number of Subjects Who Achieved Mean 24-hour Ambluatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment
participants	Overall Study
BP<140/90 mm Hg	133
SBP<140 mm Hg	133
DBP<90 mm Hg	149

SecondaryNumber of Subjects Who Achieved Mean Daytime (8am - 4pm) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment.

All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.

Time frame:: baseline to 12 weeks
Reported as:: Number · participants

Number of Subjects Who Achieved Mean Daytime (8am - 4pm) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment.
participants	Overall Study
BP<140/90 mm Hg	120
SBP<140 mm Hg	120
DBP<90 mm Hg	145

SecondaryNumber of Subjects Who Achieved Mean Nighttime (10pm - 6am) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment.

All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.

Time frame:: baseline to 12 weeks
Reported as:: Number · participants

Number of Subjects Who Achieved Mean Nighttime (10pm - 6am) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment.
participants	Overall Study
BP<140/90 mm Hg	143
SBP<140 mm Hg	143
DBP<90 mm Hg	149

Baseline characteristics

Age Continuous
Age Continuous(years)	Active Treatment Period
Mean	72.0 ± 5.3

Sex: Female, Male
Sex: Female, Male(Participants)	Active Treatment Period
Female	85
Male	93

Region of Enrollment
Region of Enrollment(participants)	Active Treatment Period
United States	178

Baseline stage of hypertension
Baseline stage of hypertension(participants)	Active Treatment Period
Stage 1 hypertension	62
Stage 2 hypertension	116

Baseline 24-hour ambulatory diastolic blood pressure
Baseline 24-hour ambulatory diastolic blood pressure(mm Hg)	Active Treatment Period
Mean	80.7 ± 8.5

Baseline 24-hour ambulatory systolic blood pressure
Baseline 24-hour ambulatory systolic blood pressure(mm Hg)	Active Treatment Period
Mean	149.1 ± 11.2

Baseline diastolic blood pressure
Baseline diastolic blood pressure(mm Hg)	Active Treatment Period
Mean	87.7 ± 9.6

Baseline heart rate
Baseline heart rate(beats/minute)	Active Treatment Period
Mean	71.5 ± 11.4

1 further baseline measures are reported on the registry.

08

Study locations

29 sites

Birmingham, Alabama, United States
Mesa, Arizona, United States
Long Beach, California, United States
Los Angeles, California, United States
Pomona, California, United States
Roseville, California, United States
Tustin, California, United States
Farmington, Connecticut, United States
Jupiter, Florida, United States
Lauderdale lakes, Florida, United States
New Port Richey, 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
Florissant, Missouri, United States
Berlin, New Jersey, United States
Williamsville, New York, United States
Charlotte, North Carolina, United States
Cincinnati, Ohio, United States
Oklahoma City, Oklahoma, United States
Greer, South Carolina, United States
Corpus Christi, Texas, United States
Richardson, Texas, United States
Norfolk, Virginia, United States
Madison, Wisconsin, United States

09

References and documents

Publications

Germino FW, Neutel JM, Dubiel R, Maa JF, Chavanu KJ. Efficacy of olmesartan medoxomil and hydrochlorothiazide fixed-dose combination therapy in patients aged 65 years and older with stage 1 and 2 hypertension or isolated systolic hypertension. Am J Cardiovasc Drugs. 2012 Oct 1;12(5):325-33. doi: 10.1007/BF03261841. PubMed 22920048 ↗
Neutel J, Kereiakes DJ, Stoakes KA, Maa JF, Shojaee A, Waverczak WF. Blood pressure-lowering efficacy of an olmesartan medoxomil/hydrochlorothiazide-based treatment algorithm in elderly patients (age >/=65 years) stratified by age, sex and race: subgroup analysis of a 12-week, open-label, single-arm, dose-titration study. Drugs Aging. 2011 Jun 1;28(6):477-90. doi: 10.2165/11589460-000000000-00000. PubMed 21639407 ↗

10

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 22, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID: NCT00412932
Lead sponsor: Daiichi Sankyo
First posted: Dec 19, 2006
Start date: Dec 2006
Primary completion: Apr 2008
Completion: Apr 2008
Results posted: Sep 11, 2009
Last update: Sep 22, 2009

View the source record on ClinicalTrials.gov ↗

An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Elderly Patients With Hypertension

Study summary

Conditions studied

Browse trials for

Keywords

In context

Hypertension

Lead sponsor

Who can participate

Inclusion criteria

Exclusion criteria

Study design

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

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

An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Elderly Patients With Hypertension

Study summary

Conditions studied

Browse trials for

Keywords

In context

Hypertension

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

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