Blood Pressure Lowering Ability and Safety of an Olmesartan and Amlodipine Based Treatment Regimen in Patients With Stage I and Stage II Hypertension

This study is ongoing, but not recruiting participants.

First Received: September 10, 2007 Last Updated: March 27, 2008 History of Changes

Sponsored by:	Daiichi Sankyo Inc.
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00527514

Purpose

This study will be conducted to assess the efficacy and safety of an amlodipine/olmesartan treatment regimen in stage 1 and stage 2 hypertensive subjects.

Condition	Intervention	Phase
Hypertension	Drug: Amlodipine Drug: Olmesartan medoxomil plus amlodipine	Phase III

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate 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 Study to Assess the Efficacy and Safety of an Olmesartan and Amlodipine Based Treatment Regimen in Subjects With Stage 1 and Stage 2 Hypertension

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:

To demonstrate that an olmesartan and amlodipine based treatment regimen significantly lowers systolic blood pressure (SBP) after treatment, as measured by ambulatory blood pressure monitoring (ABPM). [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the change from baseline in mean DBP after active treatment as measured by ABPM. To assess the change from baseline in mean ABPM SBP and mean ABPM DBP. To evaluate the change from baseline in SBP and DBP after active treatment. [ Time Frame: Various time points ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	September 2007
Estimated Study Completion Date:	April 2008
Estimated Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Amlodipine Tablets Drug: Olmesartan medoxomil plus amlodipine Tablets

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or females greater than or equal to 18 years of age
Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to 140 mm Hg but less than or equal to 199 mm Hg or a MSDBP greater than or equal to 90 mm Hg and less than or equal to 109 mm Hg, following a period of taking only placebo
Patients with a mean daytime (8AM-4PM) SBP greater than or equal to 135 mm Hg and less than or equal to 199 mm Hg and a mean daytime DBP less than or equal to 109 mm Hg as measured by an ambulatory blood pressure monitoring device (ABPM), after a period of taking only placebo
If female, must have negative serum pregnancy test at screening and be either post-menopausal (greater than or equal to 1 year), 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:

History of stroke or transient ischemic attack (TIA) within the last one year
History of myocardial infarction, coronary angioplasty, coronary artery bypass graft, or heart failure within the past 6 months
Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or Cushing's syndrome
Type I diabetes. Patients with Type II diabetes on stable treatment, with fasting glucose < 160 mg/dl may enroll
Patients with hemodynamically significant cardiac valvular disease
Patients with clinically significant cardiac conduction defects, including second or third degree AV block, left bundle branch block, sick sinus syndrome, atrial fibrillation, atrial flutter, an accessory bypass tract, or any arrhythmia requiring medication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527514

Locations

United States, California

Long Beach, California, United States

Sacramento, California, United States

Tustin, California, United States

Buena Park, California, United States

Westlake Village, California, United States

Los Angeles, California, United States
United States, Colorado

Castle Rock, Colorado, United States
United States, Florida

Pembroke Pines, Florida, United States
United States, Illinois

Orland Park, Illinois, United States
United States, Massachusetts

Natick, Massachusetts, United States
United States, New York

New York, New York, United States
United States, North Carolina

Winston-Salem, North Carolina, United States
United States, Ohio

Cincinnati, Ohio, United States
United States, Pennsylvania

Beaver, Pennsylvania, United States
United States, South Carolina

Greer, South Carolina, United States
United States, Texas

Corpus Christi, Texas, United States

Carrolton, Texas, United States
United States, Wisconsin

Madison, Wisconsin, United States

Sponsors and Collaborators

Daiichi Sankyo Inc.

More Information

No publications provided

Responsible Party:	Daiichi Sankyo ( William Waverczak )
Study ID Numbers:	8663-402
Study First Received:	September 10, 2007
Last Updated:	March 27, 2008
ClinicalTrials.gov Identifier:	NCT00527514 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:

Hypertension
Angiotensin Receptor Blocker
Calcium Channel Blocker
Stage I and II Hypertension

Study placed in the following topic categories:

Angiotensin II Type 1 Receptor Blockers
Calcium, Dietary
Vasodilator Agents
Vascular Diseases
Calcium Channel Blockers
Olmesartan medoxomil

Cardiovascular Agents
Angiotensin II
Antihypertensive Agents
Amlodipine
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Calcium Channel Blockers
Olmesartan medoxomil
Cardiovascular Agents
Antihypertensive Agents

Pharmacologic Actions
Amlodipine
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Therapeutic Uses
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009