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

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ClinicalTrials.gov Identifier: NCT00412932

Recruitment Status : Completed

First Posted : December 19, 2006

Results First Posted : September 11, 2009

Last Update Posted : September 22, 2009

Sponsor:

Information provided by:

Daiichi Sankyo, Inc.

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Hypertension	Drug: Olmesartan medoxomil Drug: Olmesartan medoxomil/hydrochlorothiazide	Phase 4

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	178 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Prospective, Open Label, Single Arm Study to Evaluation the Safety and Efficacy of an Olmesartan Medoxomil Based Treatment Regimen in Elderly Patients With Hypertension
Study Start Date :	December 2006
Actual Primary Completion Date :	April 2008
Actual Study Completion Date :	April 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Olmesartan Olmesartan medoxomil

U.S. FDA Resources

Arms and Interventions

Intervention Details:

Drug: Olmesartan medoxomil
Tablets
Drug: Olmesartan medoxomil/hydrochlorothiazide
Tablets

Outcome Measures

Primary Outcome Measures :

Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment [ Time Frame: baseline to 12 weeks ]

Secondary Outcome Measures :

Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure After 12 Weeks of Active Treatment. [ 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 [ 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 [ 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 [ 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. [ 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. [ Time Frame: baseline to 12 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	65 Years and older (Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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:

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00412932

Show 29 Study Locations

Sponsors and Collaborators

Daiichi Sankyo, Inc.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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: 10.2165/11635000-000000000-00000.

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.


Responsible Party:	William Waverczak, Daiichi Sankyo
ClinicalTrials.gov Identifier:	NCT00412932 History of Changes
Other Study ID Numbers:	866-450
First Posted:	December 19, 2006 Key Record Dates
Results First Posted:	September 11, 2009
Last Update Posted:	September 22, 2009
Last Verified:	September 2009

Keywords provided by Daiichi Sankyo, Inc.:


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

Additional relevant MeSH terms:


Hypertension Vascular Diseases Cardiovascular Diseases Olmesartan Hydrochlorothiazide Olmesartan Medoxomil Angiotensin-Converting Enzyme Inhibitors Antihypertensive Agents Diuretics	Natriuretic Agents Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Protease Inhibitors Enzyme Inhibitors

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