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Trial record 76 of 134 for:    OLMESARTAN

Study of Co-administration of Olmesartan Medoxomil Plus Amlodipine in Patients With Mild to Severe 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: NCT00185133
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : December 24, 2018
Sponsor:
Information provided by:
Daiichi Sankyo, Inc.

Brief Summary:
This study assesses the efficacy and safety of co-administration of olmesartan medoxomil plus amlodipine in mild to severe hypertensive patients older than 18 years of age

Condition or disease Intervention/treatment Phase
Hypertension Drug: Olmesartan medoxomil Drug: Amlodipine Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Factorial Study Evaluating the Efficacy and Safety of Co-administration of Olmesartan Medoxomil Plus Amlodipine Compared to Monotherapy in Patients With Mild to Severe Hypertension
Study Start Date : May 2005
Study Completion Date : January 2007

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Primary Outcome Measures :
  1. Change from baseline in trough seated systolic blood pressure and seated diastolic blood pressure for each treatment arm

Secondary Outcome Measures :
  1. To evaluate the number (%) of patients achieving BP goal.
  2. To characterize the pharmacokinetic interactions and the corresponding pharmacodynamic (BP) correlation


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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:

  • Male or female patients
  • 18 years of age or older (20% equal to or older than 65 years)
  • With mild to severe hypertension defined as seated diastolic blood pressure of 95-120 mmHg while off any hypertensive medication

Exclusion Criteria:

  • Patients should not have serious concomitant conditions that could interfere with the analysis of the results or that could interfere with the well-being of the patients

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): NCT00185133


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Sponsors and Collaborators
Daiichi Sankyo, Inc.

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Responsible Party: Reinilde Heyrman, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00185133     History of Changes
Other Study ID Numbers: CS8663-A-U301
First Posted: September 16, 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/
Keywords provided by Daiichi Sankyo, Inc.:
Treatment of high blood pressure in mild to severe hypertensive patients
Additional relevant MeSH terms:
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Olmesartan
Olmesartan Medoxomil
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists