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Olmesartan as an Add-on to Amlodipine in Hypertension

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00220233
First received: September 16, 2005
Last updated: December 12, 2007
Last verified: December 2007
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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
Leipzig, Germany
Sinsheim, Germany
Tann, Germany
Weinheim, Germany
Wiesbaden, Germany
Sponsors and Collaborators
Sankyo Pharma Gmbh
Investigators
Principal Investigator: Peter Brommer, MD
  More Information

No publications provided

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Olmesartan medoxomil
Amlodipine
Olmesartan
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Calcium Channel Blockers
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on June 17, 2013