Combination of Nebivolol and Valsartan Given as Free Tablets for Stage 1 or Stage 2 Hypertension
Recruiting in Palo Alto (17 mi)
+134 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Forest Laboratories
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The purpose of this study is to evaluate the safety and tolerability of nebivolol and valsartan given as a free tablet combination in patient with stage 1 or stage 2 essential hypertension.
Eligibility Criteria
Inclusion Criteria
Male or female outpatients of age 18 years or above
Patients diagnosed with stage 1 or stage 2 essential hypertension
Normal physical examination findings, electrocardiogram (ECG) results and chest x-ray; or abnormal findings judged by the Investigator to be not clinically significant
Treatment Details
Interventions
- Hydrochlorothiazide (Diuretic)
- Nebivolol (Beta Blocker)
- Valsartan (Angiotensin II Receptor Blocker)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
Nebivolol and Valsartan free tablet combination
Nebivolol is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Bystolic for:
- Hypertension
🇪🇺 Approved in European Union as Nebivolol for:
- Essential hypertension
- Heart failure
🇨🇦 Approved in Canada as Nebivolol for:
- Hypertension
- Heart failure
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Forest Investigative Site 135Carmichael, CA
Forest Investigative Site 071Troy, MI
Forest Investigative Site 039Upper St. Clair, PA
Forest Investigative Site 037Norfolk, VA
More Trial Locations
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Who Is Running the Clinical Trial?
Forest LaboratoriesLead Sponsor