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Amlodipine as Add-on to Olmesartan in Hypertension

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ClinicalTrials.gov Identifier: NCT00220220
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : October 11, 2007
Sponsor:
Information provided by:
Daiichi Sankyo, Inc.

Study Description
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Brief Summary:
Test the efficacy and safety of the combination of olmesartan and amlodipine in hypertensive patients whose blood pressure is not adequately controlled with olmesartan alone.

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: olmesartan medoxomil Drug: amlodipine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 429 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Amlodipine Used as Add-on Therapy in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil 20 mg Monotherapy
Study Start Date : April 2005
Actual Study Completion Date : April 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Mean change in trough sitting diastolic blood pressure (dBP) assessed by conventional BP measurements after 8 weeks of double-blind treatment.

Secondary Outcome Measures :
  1. Mean change in trough sitting sBP and mean BP daytime, nighttime and 24h ABPM after 8 weeks of double-blind treatment.
  2. Responder rate, defined as number (%) of patients achieving BP goals during 8 weeks of double-blind treatment.
  3. Safety and tolerability

Eligibility Criteria
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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:

  • Mean sitting BP of greater than or equal to 140/90-115 mmHg and mean 24h dBP greater than or equal to 80 mmHg with at least 30% of daytime readings greater than 85 mmHg prior to randomization.

Exclusion Criteria:

  • Secondary hypertension of any aetiology;
  • Any serious disorders which may limit the ability to evaluate the efficacy or safety of the test drug(s);
  • History of myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, congestive heart failure, hypertensive encephalopathy, stroke or TIA within the last 6 months.
Contacts and Locations
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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): NCT00220220


Locations
Germany
Hamburg, Germany
Magdeburg, Germany
Messkirch, Germany
Stuhr, Germany
Tann, Germany
Worpswede, Germany
Sponsors and Collaborators
Sankyo Pharma Gmbh
Investigators
Principal Investigator: Peter Brommer, MD
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00220220     History of Changes
Other Study ID Numbers: CS8663-A-E302
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: October 11, 2007
Last Verified: October 2007

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