Olmesartan as an Add-on to Amlodipine in Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00220233
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : December 14, 2007
Information provided by:
Daiichi Sankyo, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Essential Hypertension Drug: olmesartan medoxomil Drug: amlodipine Drug: hydrochlorothiazide Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 632 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2005
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Mean change in trough seated diastolic blood pressure

Secondary Outcome Measures :
  1. Mean change in trough seated systolic BP
  2. Mean change in daytime, nighttime and 24 hour ambulatory blood pressure
  3. Percent of patients achieving target blood pressure goal
  4. Safety and tolerability

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00220233

Leipzig, Germany
Sinsheim, Germany
Tann, Germany
Weinheim, Germany
Wiesbaden, Germany
Sponsors and Collaborators
Sankyo Pharma Gmbh
Principal Investigator: Peter Brommer, MD Identifier: NCT00220233     History of Changes
Other Study ID Numbers: CS8663-A-E303
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: December 14, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Olmesartan Medoxomil
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists