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

Sponsored by:	Daiichi Sankyo Inc.
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00412932

Purpose

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	Intervention	Phase
Hypertension	Drug: Olmesartan medoxomil Drug: Olmesartan medoxomil/hydrochlorothiazide	Phase IV

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Calcium gluconate Hydrochlorothiazide Olmesartan Olmesartan medoxomil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:

Change from baseline in Systolic BP (SBP) after 12 weeks of active treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
as measured by 24-hour ABPM. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in mean 24-hour ABPM Diastolic BP (DBP) after 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
of active treatment. Change from baseline in mean daytime (8am-4pm) and [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
mean nightime (10 pm-6am) ABPM SBP and DBP after 12 weeks of active [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	December 2006
Estimated Study Completion Date:	April 2008
Estimated Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Tablets

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or Females greater than 65 years
Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to 150 mmHg but less than 200 mm Hg and a MSDBP less than or equal to 109 mmHg following a 2-3 wk 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) SBP greater than or equal to 140 mmHG and less than or equal to 199 mmHg and a mean daytime 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 (DBP greater than 115 mm Hg or SBP greater than or equal to 200 mm Hg).
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 wks. 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412932

Show 29 Study Locations

Sponsors and Collaborators

Daiichi Sankyo Inc.

More Information

Responsible Party:	Daiichi Sankyo ( William Waverczak )
Study ID Numbers:	866-450
Study First Received:	December 14, 2006
Last Updated:	March 28, 2008
ClinicalTrials.gov Identifier:	NCT00412932
Health Authority:	United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:

Hypertension
Angiotensin Receptor Blocker
Calcium Channel Blocker

Angiotensin Converting Enzyme Inhibitor
Hydrochlorothiazide
Stage I and II Hypertension

Study placed in the following topic categories:

Calcium, Dietary
Vascular Diseases
Olmesartan medoxomil

Angiotensin II
Hydrochlorothiazide
Hypertension

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Therapeutic Uses
Sodium Chloride Symporter Inhibitors

Physiological Effects of Drugs
Diuretics
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009