Combination of Nebivolol and Valsartan Given as Free Tablets for Stage 1 or Stage 2 Hypertension

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: Nebivolol, Valsartan and Hydrochlorothiazide

• Registration Number: NCT01415505
• Lead Sponsor: Forest Laboratories

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-10
• Study First Submitted QC: 2011-08-11
• Study First Posted: 2011-08-12
• Primary Completion: 2013-01
• Study Completion: 2013-04
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-31
• Last Update Posted: 2013-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 812

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

Exclusion Criteria

• Secondary hypertension or severe hypertension
• Clinically significant cardiovascular disease or heart failure
• A medical contraindication to discontinuing a current antihypertensive therapy
• History of Type 1 diabetes mellitus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Nebivolol, Valsartan and Hydrochlorothiazide	Nebivolol and Valsartan free tablet combination

Primary Outcome Measures

Name	Time	Method
Adverse Event Recording	From Baseline to Week 53 (Visit 16)

Secondary Outcome Measures

Name	Time	Method
Systolic Blood Pressure (SBP)	From Baseline to Week 52 (Visit 15)
Diastolic Blood Pressure (DBP).	From Baseline to Week 52 (Visit 15)

Trial Locations

Locations (135)

Forest Investigative Site 083; 🇺🇸 Birmingham, Alabama, United States

Forest Investigative Site 004; 🇺🇸 Foley, Alabama, United States

Forest Investigative Site 038; 🇺🇸 Gulf Shores, Alabama, United States

Forest Investigative Site 124; 🇺🇸 Muscle Shoals, Alabama, United States

Forest Investigative Site 023; 🇺🇸 Chandler, Arizona, United States

Forest Investigative Site 073; 🇺🇸 Goodyear, Arizona, United States

Forest Investigative Site 100; 🇺🇸 Green Valley, Arizona, United States

Forest Investigative Site 117; 🇺🇸 Mesa, Arizona, United States

Forest Investigative Site 065; 🇺🇸 Mesa, Arizona, United States

Forest Investigative Site 102; 🇺🇸 Phoenix, Arizona, United States

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