Olmesartan as an Add-on to Amlodipine in Hypertension

This study has been completed.

First Received: September 16, 2005 Last Updated: December 12, 2007 History of Changes

Sponsored by:	Sankyo Pharma Gmbh
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00220233

Purpose

This study is to test the efficacy and safety of the combination of olmesartan and amlodipine in hypertensive patients whose blood pressure is not adequately controlled with amlodipine alone

Condition	Intervention	Phase
Essential Hypertension	Drug: olmesartan medoxomil Drug: amlodipine Drug: hydrochlorothiazide	Phase III

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Amlodipine Amlodipine besylate Olmesartan Olmesartan medoxomil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Add-on Study of Olmesartan Medoxomil in Patients With Moderate to Severe Hypertension Not Achieving Target Blood Pressure on Amlodipine 5 mg Alone

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:

Mean change in trough seated diastolic blood pressure

Secondary Outcome Measures:

Mean change in trough seated systolic BP
Mean change in daytime, nighttime and 24 hour ambulatory blood pressure
Percent of patients achieving target blood pressure goal
Safety and tolerability

Estimated Enrollment:	632
Study Start Date:	April 2005
Study Completion Date:	August 2007

Eligibility

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

Criteria

Inclusion Criteria:

Without antihypertensive pre-treatment mean seated BP greater than 160/100 mmHg
Pre-treatment with amlodipine 5 or 10 mg: mean seated BP greater than or equal to 140/90 mmHg

Exclusion Criteria:

Secondary hypertension
Any serious disorder which may limit the ability to evaluate the efficacy or safety of the test drugs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220233

Locations

Germany

Tann, Germany

Leipzig, Germany

Sinsheim, Germany

Weinheim, Germany

Wiesbaden, Germany

Sponsors and Collaborators

Sankyo Pharma Gmbh

Investigators

Principal Investigator:

Peter Brommer, MD

Unaffiliated

More Information

No publications provided

Study ID Numbers:	CS8663-A-E303
Study First Received:	September 16, 2005
Last Updated:	December 12, 2007
ClinicalTrials.gov Identifier:	NCT00220233 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Essential Hypertension
Vasodilator Agents
Diuretics
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Calcium Channel Blockers
Olmesartan medoxomil
Cardiovascular Agents

Angiotensin II
Antihypertensive Agents
Hydrochlorothiazide
Amlodipine
Angiotensin II Type 1 Receptor Blockers
Calcium, Dietary
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Calcium Channel Blockers
Olmesartan medoxomil
Cardiovascular Agents
Antihypertensive Agents

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

ClinicalTrials.gov processed this record on May 06, 2009