A Dose Escalation Study of a Combination Antihypertensive Drug in the Treatment of Various Groups of Patients Who do Not Respond to Single Drug Treatment of Their High Blood Pressure
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/11/2019 |
| Start Date: | November 2008 |
| End Date: | September 2009 |
A Prospective, Open-Label, Titration Study to Evaluate the Efficacy and Safety Safety of AZOR in Multiple Subgroups of Hypertensive Subjects Who Are Non-Responders to Anti-Hypertensive Monotherapy
The initial 12 week portion of this 20 week study will examine the ability of a combination
of olmesartan medoxomil and amlodipine to lower the blood pressure of patients with high
blood pressure who have not had sufficient blood pressure reduction using one
anti-hypertension drug (monotherapy). The final 8 weeks of this 20 week study will examine
the ability of a combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide to
lower blood pressure in the same patient population. All three medications being tested have
been approved by the FDA for the treatment of high blood pressure, but only amlodipine and
olmesartan are currently approved for use in combination form.
of olmesartan medoxomil and amlodipine to lower the blood pressure of patients with high
blood pressure who have not had sufficient blood pressure reduction using one
anti-hypertension drug (monotherapy). The final 8 weeks of this 20 week study will examine
the ability of a combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide to
lower blood pressure in the same patient population. All three medications being tested have
been approved by the FDA for the treatment of high blood pressure, but only amlodipine and
olmesartan are currently approved for use in combination form.
Inclusion Criteria:
- >= to 18 years of age
- Hypertension uncontrolled on current monotherapy
- Females:
- negative serum pregnancy test at screening
- post menopausal or have had a hysterectomy or tubal ligation or practicing approved
methods of birth control
Exclusion Criteria:
- Pregnant females
- Uncontrolled hypertension with multiple drugs, except for
hydrochlorothiazide/triamterene
- Diabetes requiring insulin
- Serious disorders that may limit the ability to evaluate the efficacy or safety of
treatment
- History of myocardial infarction, bypass graft, angioplasty or heart failure within
the past 6 months
- History of Class III or IV congestive heart failure
- History of stroke or transient ischemic attack within the last 1 year
We found this trial at
72
sites
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