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Study of co-Administration of Olmesartan Medoxomil Plus Amlodipine in Patients With Mild to Severe Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00185133
First Posted: September 16, 2005
Last Update Posted: December 14, 2007
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.
Information provided by:
Daiichi Sankyo, Inc.
  Purpose
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 Intervention Phase
Hypertension Drug: Olmesartan medoxomil Drug: Amlodipine Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo, Inc.:

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

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

Estimated Enrollment: 1900
Study Start Date: May 2005
Estimated Study Completion Date: January 2007
  Eligibility

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
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00185133


  Show 139 Study Locations
Sponsors and Collaborators
Daiichi Sankyo, Inc.
  More Information

Responsible Party: Reinilde Heyrman, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00185133     History of Changes
Other Study ID Numbers: CS8663-A-U301
First Submitted: September 9, 2005
First Posted: September 16, 2005
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:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Olmesartan
Amlodipine
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