Study of the Efficacy and Safety of the Combination of Two FDA Approved Oral Medications, Nebivolol and Valsartan for Treatment of Stage 1 or 2 Hypertension

Completed · Phase 3 · Has a placebo group

Conditions studied: Stage 1 Hypertension, Stage 2 Hypertension

In brief

To evaluate the efficacy and safety of fixed-dose combination of nebivolol and valsartan compared to monotherapy and placebo in patients with stage 1 and stage 2 hypertension.

Key facts

Study ID

NCT01508026

Run by

Forest Laboratories

People needed

4161

Starts

2012-01-01

Expected to finish

2013-05-01

Last updated by the study team

2014-04-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Secondary hypertension or severe hypertension
• Clinically significant cardiovascular disease or heart failure
• Clinical significant respiratory disease that would prohibit the use of a beta blocker
• A medical contraindication to discontinuing a current antihypertensive therapy
• History of Type 1 diabetes mellitus
• History of Severe Mental Illness except mild depression

Where it is running

• Forest Investigative Site 1038 — Birmingham, Alabama, United States
• Forest Investigative Site 1308 — Birmingham, Alabama, United States
• Forest Investigative Site 1192 — Birmingham, Alabama, United States
• Forest Investigative Site 1005 — Birmingham, Alabama, United States
• Forest Investigative Site 1047 — Foley, Alabama, United States
• Forest Investigative Site 1717 — Gulf Shores, Alabama, United States
• Forest Investigative Site 1056 — Mobile, Alabama, United States
• Forest Investigative Site 1719 — Muscle Shoals, Alabama, United States
• Forest Investigative Site 1145 — Glendale, Arizona, United States
• Forest Investigative Site 1703 — Goodyear, Arizona, United States
• Forest Investigative Site 1757 — Mesa, Arizona, United States
• Forest Investigative Site 1170 — Phoenix, Arizona, United States
• Forest Investigative Site 1238 — Phoenix, Arizona, United States
• Forest Investigative Site 1204 — Phoenix, Arizona, United States
• Forest Investigative Site 1755 — Phoenix, Arizona, United States
• Forest Investigative Site 1259 — Phoenix, Arizona, United States
• Forest Investigative Site 1001 — Phoenix, Arizona, United States
• Forest Investigative Site 1078 — Scottsdale, Arizona, United States
• Forest Investigative Site 1225 — Tempe, Arizona, United States
• Forest Investigative Site 1712 — Tempe, Arizona, United States
• Forest Investigative Site 1089 — Tempe, Arizona, United States
• Forest Investigative Site 1065 — Tucson, Arizona, United States
• Forest Investigative Site 1340 — Tucson, Arizona, United States
• Forest Investigative Site 1331 — Tucson, Arizona, United States
• Forest Investigative Site 1750 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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