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Study of co-Administration of Olmesartan Medoxomil Plus Amlodipine in Patients With Mild to Severe Hypertension
This study has been completed.
Sponsor:
Daiichi Sankyo Inc.
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00185133
First received: September 9, 2005
Last updated: December 12, 2007
Last verified: December 2007
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Hypertension | Drug: Olmesartan medoxomil Drug: Amlodipine | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
Resource links provided by NLM:
Further study details as provided by Daiichi Sankyo Inc.:
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
| Estimated Enrollment: | 1900 |
| Study Start Date: | May 2005 |
| Estimated Study Completion Date: | January 2007 |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00185133
Show 139 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00185133
Show 139 Study Locations
Sponsors and Collaborators
Daiichi Sankyo Inc.
More Information
| Responsible Party: | Reinilde Heyrman, Daiichi Sankyo |
| ClinicalTrials.gov Identifier: | NCT00185133 History of Changes |
| Other Study ID Numbers: |
CS8663-A-U301 |
| Study First Received: | September 9, 2005 |
| Last Updated: | December 12, 2007 |
Keywords provided by Daiichi Sankyo Inc.:
|
Treatment of high blood pressure in mild to severe hypertensive patients |
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 |
ClinicalTrials.gov processed this record on June 23, 2017