Study of Co-administration of Olmesartan Medoxomil Plus Amlodipine in Patients With Mild to Severe Hypertension
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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 |
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Recruitment Status :
Completed
First Posted : September 16, 2005
Last Update Posted : December 24, 2018
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Sponsor:
Daiichi Sankyo, Inc.
Information provided by:
Daiichi Sankyo, Inc.
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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 |
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Hypertension
Primary Outcome Measures :
- Change from baseline in trough seated systolic blood pressure and seated diastolic blood pressure for each treatment arm
Secondary Outcome Measures :
- To evaluate the number (%) of patients achieving BP goal.
- To characterize the pharmacokinetic interactions and the corresponding pharmacodynamic (BP) correlation
Information from the National Library of Medicine
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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
Locations
Show 139 study locations
Sponsors and Collaborators
Daiichi Sankyo, Inc.
| Responsible Party: | Reinilde Heyrman, Daiichi Sankyo |
| ClinicalTrials.gov Identifier: | NCT00185133 |
| 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.:
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Treatment of high blood pressure in mild to severe hypertensive patients |
Additional relevant MeSH terms:
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Hypertension Vascular Diseases Cardiovascular Diseases Amlodipine Olmesartan Olmesartan Medoxomil 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 |