This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Olmesartan as an Add-on to Amlodipine in Hypertension

This study has been completed.
Information provided by:
Daiichi Sankyo, Inc. Identifier:
First received: September 16, 2005
Last updated: December 12, 2007
Last verified: December 2007
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 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00220233

Leipzig, Germany
Sinsheim, Germany
Tann, Germany
Weinheim, Germany
Wiesbaden, Germany
Sponsors and Collaborators
Sankyo Pharma Gmbh
Principal Investigator: Peter Brommer, MD
  More Information Identifier: NCT00220233     History of Changes
Other Study ID Numbers: CS8663-A-E303
Study First Received: September 16, 2005
Last Updated: December 12, 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 processed this record on September 25, 2017