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Trial record 79 of 134 for:    OLMESARTAN

Olmesartan as an add-on to Amlodipine in Hypertension

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.
 
ClinicalTrials.gov Identifier: NCT00220233
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : December 24, 2018
Sponsor:
Information provided by:
Daiichi Sankyo, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Essential Hypertension Drug: olmesartan medoxomil Drug: amlodipine Drug: hydrochlorothiazide Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 632 participants
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
Study Start Date : April 2005
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Mean change in trough seated diastolic blood pressure

Secondary Outcome Measures :
  1. Mean change in trough seated systolic BP
  2. Mean change in daytime, nighttime and 24 hour ambulatory blood pressure
  3. Percent of patients achieving target blood pressure goal
  4. Safety and tolerability


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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:

  • 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

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): NCT00220233


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

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ClinicalTrials.gov Identifier: NCT00220233     History of Changes
Other Study ID Numbers: CS8663-A-E303
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2007
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
URL: https://vivli.org/ourmember/daiichi-sankyo/
Additional relevant MeSH terms:
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Olmesartan
Olmesartan Medoxomil
Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Hydrochlorothiazide
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists