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| Sponsor: | Daiichi Sankyo Inc. |
|---|---|
| Information provided by: | Daiichi Sankyo Inc. |
| ClinicalTrials.gov Identifier: | NCT00185068 |
Purpose
Effect of increasing doses of olmesartan medoxomil and olmesartan medoxomil/hydrochlorothiazide on blood pressure in patients with hypertension
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Olmesartan medoxomil Drug: Olmesartan medoxomil/hydrochlorothiazide Drug: Hydrochlorothiazide |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Prospective, Open Label, Titration Study to Assess the Efficacy and Safety of Benicar® and Benicar ®HCT in Patients With Stage II Systolic Hypertension |
| Estimated Enrollment: | 110 |
| Study Start Date: | March 2004 |
| Estimated Study Completion Date: | October 2004 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
1. Hypertensive encephalopathy, stroke or transient ischemic attack (TIA) within the past 6 months.
2. History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months.
3. Severe hypertension (DBP greater than or equal to 110 mm Hg or SBP > 200 mm Hg).
4. History of secondary hypertension including renal disease, phaeochromocytoma, or Cushing's disease.
5. Type I diabetes mellitus. 6. Evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease.
7. Presence of heart block greater than first degree sinoatrial block, Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, Atrial fibrillation, or Atrial Flutter.
8. Laboratory test values considered clinically significant by the investigator.
9. Evidence of liver disease as indicated by SGOT or SGPT and/or total bilirubin > 3 times the upper limit of normal.
10. Pregnant or lactating females.
Contacts and Locations| United States, California | |
| Long Beach, California, United States | |
| Westlake Village, California, United States | |
| Roseville, California, United States | |
| Sacramento, California, United States | |
| Fort Lauderdale, California, United States | |
| Santa Anna, California, United States | |
| Tustin, California, United States | |
| United States, Florida | |
| Pembroke Pines, Florida, United States | |
| Deland, Florida, United States | |
| United States, Illinois | |
| Orland Park, Illinois, United States | |
| United States, Louisiana | |
| New Orleans, Louisiana, United States | |
| United States, Maine | |
| Auburn, Maine, United States | |
| United States, Nebraska | |
| Omaha, Nebraska, United States | |
| United States, New York | |
| Buffalo, New York, United States | |
| United States, Oklahoma | |
| Oklahoma City, Oklahoma, United States | |
| United States, Wisconsin | |
| Madison, Wisconsin, United States | |
More Information
| Study ID Numbers: | 866-443 |
| Study First Received: | September 9, 2005 |
| Last Updated: | September 9, 2005 |
| ClinicalTrials.gov Identifier: | NCT00185068 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Systolic hypertension, Angiotensin receptor blocker |
|
Molecular Mechanisms of Pharmacological Action Diuretics Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Vascular Diseases Olmesartan medoxomil Cardiovascular Agents Antihypertensive Agents |
Hydrochlorothiazide Pharmacologic Actions Angiotensin II Type 1 Receptor Blockers Membrane Transport Modulators Natriuretic Agents Therapeutic Uses Cardiovascular Diseases Hypertension |