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

Phase 3

Completed

• Conditions: Stage 1 Hypertension; Stage 2 Hypertension
• Interventions: Drug: Placebo; Drug: Valsartan 2; Drug: Nebivolol and Valsartan 3; Drug: Nebivolol 1; Drug: Nebivolol 2; Drug: Valsartan 1; Drug: Nebivolol and Valsartan 1; Drug: Nebivolol and Valsartan 2

• Registration Number: NCT01508026
• Lead Sponsor: Forest Laboratories

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-09
• Study First Submitted QC: 2012-01-09
• Study First Posted: 2012-01-11
• Primary Completion: 2013-03
• Study Completion: 2013-05
• Status Verified: 2014-03
• Disposition First Submitted: 2014-03-28
• Disposition First Submitted QC: 2014-03-28
• Last Update Submitted: 2014-03-28
• Disposition First Posted: 2014-04-25
• Last Update Posted: 2014-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4161

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
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Dose Matched placebo
Valsartan High Dose	Valsartan 2	Valsartan Monotherapy 160 mg
Nebivolol and Valsartan Fixed Dose Combination 3	Nebivolol and Valsartan 3	Fixed Dose Combination Nebivolol 10 mg and Valsartan 160 mg
Nebivolol Low Dose	Nebivolol 1	Nebivolol Monotherapy 5 mg
Nebivolol High Dose	Nebivolol 2	Nebivolol Monotherapy 20 mg
Valsartan Low Dose	Valsartan 1	Valsartan Monotherapy 80 mg
Nebivolol and Valsartan Fixed Dose Combination 1	Nebivolol and Valsartan 1	Fixed Dose Combination Nebivolol 5 mg and Valsartan 80 mg
Nebivolol and Valsartan Fixed Dose Combination 2	Nebivolol and Valsartan 2	Fixed Dose Combination Nebivolol 5 mg and Valsartan 160 mg

Primary Outcome Measures

Name	Time	Method
Change in Sitting Diastolic Blood Pressure (DBP)	from basline to Week 8

Secondary Outcome Measures

Name	Time	Method
Change in Sitting Systolic Blood Pressure (SBP)	from baseline to Week 8

Trial Locations

Locations (413)

Forest Investigative Site 1750; 🇺🇸 Birmingham, Alabama, United States

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

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