Study of co-Administration of Olmesartan Medoxomil Plus Amlodipine in Patients With Mild to Severe 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: NCT00185133
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : December 14, 2007
Information provided by:
Daiichi Sankyo, Inc.

Brief Summary:
This study assesses the efficacy and safety of co-administration of olmesartan medoxomil plus amlodipine in mild to severe hypertensive patients older than 18 years of age

Condition or disease Intervention/treatment Phase
Hypertension Drug: Olmesartan medoxomil Drug: Amlodipine Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 1900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Factorial Study Evaluating the Efficacy and Safety of co-Administration of Olmesartan Medoxomil Plus Amlodipine Compared to Monotherapy in Patients With Mild to Severe Hypertension
Study Start Date : May 2005
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change from baseline in trough seated systolic blood pressure and seated diastolic blood pressure for each treatment arm

Secondary Outcome Measures :
  1. To evaluate the number (%) of patients achieving BP goal.
  2. To characterize the pharmacokinetic interactions and the corresponding pharmacodynamic (BP) correlation

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Male or female patients
  • 18 years of age or older (20% equal to or older than 65 years)
  • With mild to severe hypertension defined as seated diastolic blood pressure of 95-120 mmHg while off any hypertensive medication

Exclusion Criteria:

  • Patients should not have serious concomitant conditions that could interfere with the analysis of the results or that could interfere with the well-being of the patients

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): NCT00185133

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Sponsors and Collaborators
Daiichi Sankyo, Inc.

Responsible Party: Reinilde Heyrman, Daiichi Sankyo Identifier: NCT00185133     History of Changes
Other Study ID Numbers: CS8663-A-U301
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: December 14, 2007
Last Verified: December 2007

Keywords provided by Daiichi Sankyo, Inc.:
Treatment of high blood pressure in mild to severe hypertensive patients

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
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists