Efficacy and Safety Study to Evaluate Combination Therapy With Nebivolol and Lisinopril vs. Placebo and Monotherapy in Patients With Stage 2 Diastolic Hypertension

Completed · Phase 4 · Has a placebo group

Conditions studied: Stage 2 Diastolic Hypertension

In brief

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 (DBP\>= 100 mmHg).

Key facts

Study ID

NCT01218100

Run by

Forest Laboratories

People needed

664

Starts

2010-10-01

Expected to finish

2011-06-01

Last updated by the study team

2012-06-21

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Forest Investigative site 080 — Tempe, Arizona, United States
• Forest Investigative site 096 — Tucson, Arizona, United States
• Forest Investigative site 038 — Buena Park, California, United States
• Forest Investigative site 075 — Burbank, California, United States
• Forest Investigative site 042 — Costa Mesa, California, United States
• Forest Investigative site 028 — Fountain Valley, California, United States
• Forest Investigative site 064 — Fresno, California, United States
• Forest Investigative site 079 — Lancaster, California, United States
• Forest Investigative site 097 — Long Beach, California, United States
• Forest Investigative site 049 — Los Angeles, California, United States
• Forest Investigative site 081 — Riverside, California, United States
• Forest Investigative site 040 — San Marino, California, United States
• Forest Investigative site 059 — San Ramon, California, United States
• Forest Investigative site 074 — Santa Ana, California, United States
• Forest Investigative site 072 — Tustin, California, United States
• Forest Investigative site 077 — Colorado Springs, Colorado, United States
• Forest Investigative site 050 — Waterbury, Connecticut, United States
• Forest Investigative site 019 — Boca Raton, Florida, United States
• Forest Investigative site 056 — Brandon, Florida, United States
• Forest Investigative site 043 — Brooksville, Florida, United States
• Forest Investigative site 035 — Fort Lauderdale, Florida, United States
• Forest Investigative site 002 — Hialeah, Florida, United States
• Forest Investigative site 003 — Miami, Florida, United States
• Forest Investigative site 067 — Miami, Florida, United States
• Forest Investigative Site #58 — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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