Status:
COMPLETED
Efficacy and Safety Study to Evaluate Combination Therapy With Nebivolol and Lisinopril vs. Placebo and Monotherapy in Patients With Stage 2 Diastolic Hypertension
Lead Sponsor:
Forest Laboratories
Conditions:
Stage 2 Diastolic Hypertension
Eligibility:
All Genders
18-64 years
Phase:
PHASE4
Brief Summary
This study will evaluate the safety and efficacy of first-line treatment with a free combination (as two separate pills) of nebivolol and lisinopril in patients with stage 2 diastolic hypertension (DB...
Eligibility Criteria
Inclusion
- male and female outpatients 18 to 64 years of age
- Females must be post-menopausal, or not pregnant and using an approved contraceptive regimen
- stage 2 diastolic hypertension (DBP \>= 100 mmHg)
Exclusion
- secondary hypertension
- evidence of other concurrent disease or conditions that might interfere with the conduct of the study
- participation in an investigational drug study within 30 days or 5 half-lives, whichever is longer, of Screening (Visit 1).
- have a history of hypersensitivity to nebivolol or other β-blockers, or any contraindication to β-blocker use
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
664 Patients enrolled
Trial Details
Trial ID
NCT01218100
Start Date
October 1 2010
End Date
June 1 2011
Last Update
June 21 2012
Active Locations (90)
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1
Forest Investigative Site #58
Scottsdale, Arizona, United States, 85254
2
Forest Investigative site 080
Tempe, Arizona, United States, 85282
3
Forest Investigative site 096
Tucson, Arizona, United States, 85741
4
Forest Investigative site 038
Buena Park, California, United States, 90620