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

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

ChemIDplus related topics:

Calcium gluconate 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

Responsible Party:	Daiichi Sankyo ( William Waverczak )
Study ID Numbers:	8663-402
First Received:	September 10, 2007
Last Updated:	March 27, 2008
ClinicalTrials.gov Identifier:	NCT00527514
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:

Vascular Diseases

Olmesartan medoxomil

Angiotensin II

Amlodipine

Hypertension

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers

Membrane Transport Modulators

Vasodilator Agents

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Calcium Channel Blockers

Cardiovascular Diseases

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2008

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