Calcium Channel Blockers (CCBs) or Diuretics as an Add-on to Olmesartan Medoxomil in Hypertension
This study has been completed.
Sponsor:
Daiichi Sankyo Co., Ltd.
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00858702
First received: March 9, 2009
Last updated: September 18, 2009
Last verified: September 2009
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Purpose
The purpose of the study is to test the efficacy and safety of the combination of Calcium Channel Blockers (CCBs)(of the dihydropyridine class) or Diuretics (of the thiazide class) and olmesartan medoxomil in essential hypertensive patients whose blood pressure is not adequately controlled with olmesartan medoxomil alone
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: olmesartan medoxomil and a CCB Drug: olmesartan medoxomil and a diuretic |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Add-on Study of CCBs or Diuretics in Essential Hypertension Not Achieving Target Blood Pressure on Olmesartan Medoxomil Alone |
Resource links provided by NLM:
Further study details as provided by Daiichi Sankyo Inc.:
Primary Outcome Measures:
- The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85 [ Time Frame: Baseline to week 8 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings) [ Time Frame: At week 8 ] [ Designated as safety issue: Yes ]
- Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values) [ Time Frame: At week 8 ] [ Designated as safety issue: Yes ]
| Enrollment: | 105 |
| Study Start Date: | February 2005 |
| Study Completion Date: | November 2005 |
| Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
olmesartan medoxomil tablets and a CCB tablet (of the dihydropyridine class), once daily for 8 weeks
|
Drug: olmesartan medoxomil and a CCB
olmesartan medoxomil tablets and a CCB tablet once daily for 8 weeks
|
|
Experimental: 2
olmesartan medoxomil and a diuretic tablet (of the thiazide class)
|
Drug: olmesartan medoxomil and a diuretic
olmesartan medoxomil tablets and a diuretic tablet, once daily for 8 weeks
|
Eligibility| Ages Eligible for Study: | 20 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Mean seated blood pressure greater than or equal to 140/90 mmHg under circumstances in pre-treatment with olmesartan medoxomil
- Mean 24-hour blood pressure evaluated by ambulatory blood pressure monitoring greater than or equal to 135/80 mmHg under circumstances in pre-treatment with olmesartan medoxomil
Exclusion Criteria:
- Patients with secondary hypertension
- Any serious disorder which may limit the ability to evaluate the efficacy or safety of the test drugs
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: NCT00858702
Please refer to this study by its ClinicalTrials.gov identifier: NCT00858702
Locations
| Japan | |
| Tokyo, Japan | |
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Investigators
| Study Director: | Research and Development Division | Daiichi Sankyo Co., Ltd. |
More Information
No publications provided
| Responsible Party: | Yoshihiro Kakehi, Daiichi Sankyo Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT00858702 History of Changes |
| Other Study ID Numbers: | OLM004-071 |
| Study First Received: | March 9, 2009 |
| Results First Received: | July 16, 2009 |
| Last Updated: | September 18, 2009 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Daiichi Sankyo Inc.:
|
Essential hypertension Combination therapy |
Additional relevant MeSH terms:
|
Hypertension Cardiovascular Diseases Vascular Diseases Diuretics Olmesartan Olmesartan medoxomil Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |
Antihypertensive Agents Cardiovascular Agents Molecular Mechanisms of Pharmacological Action Natriuretic Agents Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015