Calcium Channel Blockers (CCBs) or Diuretics as an Add-on to Olmesartan Medoxomil 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: NCT00858702 |
|
Recruitment Status :
Completed
First Posted : March 10, 2009
Results First Posted : August 26, 2009
Last Update Posted : October 11, 2017
|
Sponsor:
Daiichi Sankyo Co., Ltd.
Information provided by:
Daiichi Sankyo, Inc.
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypertension | Drug: olmesartan medoxomil and a CCB Drug: olmesartan medoxomil and a diuretic | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 105 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | February 2005 |
| Actual Primary Completion Date : | July 2005 |
| Actual Study Completion Date : | November 2005 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
|
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 |
Primary Outcome Measures :
- The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85 [ Time Frame: Baseline to week 8 ]
Secondary Outcome Measures :
- Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings) [ Time Frame: At week 8 ]Drug-related adverse events are adverse events(AEs) as determined by the Investigator that can not be denied to be related to the study drugs. The relationship between adverse events and drugs were determined by the Investigator based on his/her clinical judgement. Factors used in determining relatedness included, but are not limited to, the medical history of the participant, use of concomitant medication, and the time course from drug administration to AE occurence.
- Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values) [ Time Frame: At week 8 ]Drug-related, laboratory value change adverse events are adverse events(AEs) as determined by the Investigator that can not be denied to be related to the study drugs. The relationship between adverse events and drugs were determined by the Investigator based on his/her clinical judgement. Factors used in determining relatedness included, but are not limited to, the medical history of the participant, use of concomitant medication, and the time course from drug administration to AE occurence.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 20 Years to 74 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
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): NCT00858702
Locations
| Japan | |
| Tokyo, Japan | |
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Investigators
| Study Director: | Research and Development Division | Daiichi Sankyo Co., Ltd. |
| Responsible Party: | Yoshihiro Kakehi, Daiichi Sankyo Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT00858702 History of Changes |
| Other Study ID Numbers: |
OLM004-071 |
| First Posted: | March 10, 2009 Key Record Dates |
| Results First Posted: | August 26, 2009 |
| Last Update Posted: | October 11, 2017 |
| Last Verified: | October 2017 |
Keywords provided by Daiichi Sankyo, Inc.:
|
Essential hypertension Combination therapy |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Diuretics Olmesartan Olmesartan Medoxomil Calcium Channel Blockers |
Natriuretic Agents Physiological Effects of Drugs Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Membrane Transport Modulators |