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Completed

NCT Number: NCT01218100

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

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).

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Key information

Conditions

Stage 2 Diastolic Hypertension

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Forest Investigative site 044, Caguas, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

nebivolol and lisinopril (free combination)

Drug

nebivolol 5-mg and lisinopril 10-mg (nebivolol non-trade 5-mg tablet and overencapsulated lisinopril 10-mg tablet)/QD/oral administration/up to 12 weeks

nebivolol 20-mg and lisinopril 40-mg (nebivolol non-trade 20-mg tablet and overencapsulated lisinopril 40-mg tablet)/QD/oral administration/up to 10 weeks

nebivolol 5-mg and lisinopril 40-mg (nebivolol non-trade 5-mg tablet and overencapsulated lisinopril 40-mg tablet)/QD/oral administration/up to 6 weeks

nebivolol 20-mg and lisinopril 10-mg (nebivolol non-trade 20-mg tablet and overencapsulated lisinopril 10-mg tablet/QD/oral administration/up to 6 weeks

nebivolol monotherapy

Drug

nebivolol 5-mg (non-trade 5-mg tablet)/QD/oral administration/up to 12 weeks

nebivolol 10-mg (non-trade 10-mg tablet/QD/oral administration/for 1-week down-titration period only)

nebivolol 20-mg (non-trade 20-mg tablet)/QD/oral administration/up to 10 weeks

lisinopril monotherapy

Drug

lisinopril 10-mg (overencapsulated 10-mg tablet)/QD/oral administration/up to 12 weeks lisinopril 40-mg (overencapsulated 40-mg tablet)/QD/oral administration/up to 10 weeks

Placebo

Drug

Placebo tablet, oral administration/QD/oral administration/up to 12 weeks Placebo capsule, oral administration/QD/oral administration/up to 12 weeks

Primary outcomes

  1. The Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6.

    Time frame: Visit 6/(Week 0) and Visit 9/(Week 6)

Secondary outcomes

  1. The Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6.

    Time frame: Visit 6/(Week 0) and Visit 9/(Week 6)

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

A Randomized, Double-blind, Parallel-Group Study to Evaluate the Effects of First-Line Treatment With a Free Combination of Nebivolol and Lisinopril Compared With Placebo and the Monotherapy Components on Blood Pressure in Patients With Stage 2 Diastolic Hypertension

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 11, 2010
Registry last updated
Jun 21, 2012

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.