An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Elderly Patients With Hypertension
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ClinicalTrials.gov Identifier: NCT00412932 |
Recruitment Status :
Completed
First Posted : December 19, 2006
Results First Posted : September 11, 2009
Last Update Posted : September 22, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension | Drug: Olmesartan medoxomil Drug: Olmesartan medoxomil/hydrochlorothiazide | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 178 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Prospective, Open Label, Single Arm Study to Evaluation the Safety and Efficacy of an Olmesartan Medoxomil Based Treatment Regimen in Elderly Patients With Hypertension |
Study Start Date : | December 2006 |
Actual Primary Completion Date : | April 2008 |
Actual Study Completion Date : | April 2008 |

- Drug: Olmesartan medoxomil
Tablets
- Drug: Olmesartan medoxomil/hydrochlorothiazide
Tablets
- Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment [ Time Frame: baseline to 12 weeks ]
- Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure After 12 Weeks of Active Treatment. [ Time Frame: baseline to 12 weeks ]
- Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10pm-6am)Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment [ Time Frame: baseline to 12 weeks ]
- Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10 Pm-6am) Ambulatory Blood Pressure Monitored Diastolic Blood Pressure After 12 Weeks of Active Treatment [ Time Frame: baseline to 12 weeks ]
- Number of Subjects Who Achieved Mean 24-hour Ambluatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment [ Time Frame: baseline to 12 weeks ]
- Number of Subjects Who Achieved Mean Daytime (8am - 4pm) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment. [ Time Frame: baseline to 12 weeks ]
- Number of Subjects Who Achieved Mean Nighttime (10pm - 6am) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment. [ Time Frame: baseline to 12 weeks ]

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Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males or Females greater than 65 years of age
- Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to 150 mmHg but less than 200 mm Hg and a mean seated diastolic blood pressure (MSDBP) less than or equal to 109 mmHg following a 2-3 week single blind placebo run-in period.
- The difference in MSSBP between visits 2 and 3 or between visits 3 and 3x must be less than or equal to 10 mmHg.
- Patients with a mean daytime (8am-4pm) systolic blood pressure (SBP) greater than or equal to 140 mmHg and less than or equal to 199 mmHg and a mean daytime diastolic blood pressure (DBP) less than or equal to 109 mmHg as measured by an ambulatory blood pressure monitoring device (ABPM) following placebo run-in period.
Exclusion Criteria:
- History of stroke or transient ischemic attack (TIA) within the last one year.
- History of myocardial infarction, angina, coronary angioplasty, coronary artery bypass graft, or heart failure within the past 6 months.
- Severe hypertension (diastolic blood pressure greater than 115 mmHg or systolic blood pressure greater than or equal to 200 mmHg).
- Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma or Cushing's syndrome.
- Type I diabetes or Type II diabetics not on stable treatment for greater than or equal to 4 weeks and plasma glucose greater than 160 mg/dl.
- Evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease.
- Presence of heart block greater than first degree sinoatrial block, Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, an accessory bypass tract, atrial fibrillation, atrial flutter or any arrhythmia requiring medication.
- Serum Creatinine greater than 1.7 mg/dl, or other abnormal laboratory values deemed clinically significant by the investigator.

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): NCT00412932

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | William Waverczak, Daiichi Sankyo |
ClinicalTrials.gov Identifier: | NCT00412932 History of Changes |
Other Study ID Numbers: |
866-450 |
First Posted: | December 19, 2006 Key Record Dates |
Results First Posted: | September 11, 2009 |
Last Update Posted: | September 22, 2009 |
Last Verified: | September 2009 |
Keywords provided by Daiichi Sankyo, Inc.:
Hypertension Angiotensin Receptor Blocker Calcium Channel Blocker |
Angiotensin Converting Enzyme Inhibitor Hydrochlorothiazide Stage I and II Hypertension |
Additional relevant MeSH terms:
Hypertension Vascular Diseases Cardiovascular Diseases Olmesartan Hydrochlorothiazide Olmesartan Medoxomil Angiotensin-Converting Enzyme Inhibitors Antihypertensive Agents Diuretics |
Natriuretic Agents Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Protease Inhibitors Enzyme Inhibitors |