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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, Older Adult)
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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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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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