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Completed

NCT Number: NCT00734630

Efficacy and Safety of Nebivolol (Added to Lisinopril or Losartan) in Hypertensive Patients

This study will assess blood pressure reduction with nebivolol or placebo in patients taking lisinopril or losartan.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Forest Investigative Site 070, Gulf Shores, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, ambulatory outpatients 18-85 years old at screening
  • Have a history of hypertension
  • Qualifying laboratory results

Exclusion criteria

  • Severe hypertension, including chronic kidney disease
  • Documented congestive heart failure
  • Have clinically significant respiratory, liver, or heart disease
  • History of stroke, heart attack, or heart surgery in the last 6 months
  • Have a history of hypersensitivity to nebivolol or other beta blockers.

Treatment and study plan

nebivolol

Drug

Encapsulated Nebivolol 5mg, 10mg, 20mg, or 40mg total daily dosage, oral administration once daily

Lisinopril 10mg, 20mg total daily dosage, oral administration Losartan 50mg, 100mg total daily dosage, oral administration

Other names: Bystolic ™

Placebo

Drug

Lisinopril 10mg, 20mg total daily dosage, oral administration Losartan 50mg, 100mg total daily dosage, oral administration

Other names: Lisinopril-other names: Prinivil, Zestril, Losartan-other name: Cozaar

Primary outcomes

  1. Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12

    Time frame: From baseline Visit 5 (Week 0) to Visit 10 (Week 12)

    Change from Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12, Last Observation Carried Forward (LOCF).

Secondary outcomes

  1. Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12

    Time frame: From baseline Visit 5 (Week 0) to Visit 10 (Week 12)

    Change from Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12, Last Observation Carried Forward (LOCF).

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Nebivolol Added To Antihypertensive Treatment With Lisinopril or Losartan in Patients With Hypertension.

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 14, 2008
Registry last updated
Apr 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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