Calcium Channel Blockers (CCBs) or Diuretics as an Add-on to Olmesartan Medoxomil in Hypertension
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ClinicalTrials.gov Identifier: NCT00858702 |
Recruitment Status :
Completed
First Posted : March 10, 2009
Results First Posted : August 26, 2009
Last Update Posted : October 11, 2017
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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 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
olmesartan medoxomil tablets and a CCB tablet (of the dihydropyridine class), once daily for 8 weeks
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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 |
- The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85 [ Time Frame: Baseline to week 8 ]
- 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.

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Ages Eligible for Study: | 20 Years to 74 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Japan | |
Tokyo, Japan |
Study Director: | Research and Development Division | Daiichi Sankyo Co., Ltd. |
Responsible Party: | Yoshihiro Kakehi, Daiichi Sankyo Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT00858702 |
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 |
Essential hypertension Combination therapy |
Hypertension Essential Hypertension Vascular Diseases Cardiovascular Diseases Olmesartan Olmesartan Medoxomil Diuretics |
Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Natriuretic Agents Physiological Effects of Drugs |