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

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ClinicalTrials.gov Identifier: NCT01218100
Recruitment Status : Completed
First Posted : October 11, 2010
Results First Posted : June 21, 2012
Last Update Posted : June 21, 2012
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Stage 2 Diastolic Hypertension Drug: nebivolol and lisinopril (free combination) Drug: nebivolol monotherapy Drug: lisinopril monotherapy Drug: placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 664 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : October 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Combination group - starting dose level nebivolol 5mg and lisinopril 10mg
 Drug: nebivolol and lisinopril (free combination)

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
Active Comparator: 2
Nebivolol monotherapy group - starting dose level nebivolol 5mg
 Drug: nebivolol monotherapy

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
Active Comparator: 3
Lisinopril monotherapy group - starting dose level lisinopril 10mg
 Drug: lisinopril monotherapy
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 Comparator: 4
Placebo group - starting dose is placebo
 Drug: placebo
Placebo tablet, oral administration/QD/oral administration/up to 12 weeks Placebo capsule, oral administration/QD/oral administration/up to 12 weeks


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01218100


Locations
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Sponsors and Collaborators
Forest Laboratories
Investigators
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Study Director: Manfred Stapff, MD PhD Forest Laboratories
More Information
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Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01218100    
Other Study ID Numbers: NEB-MD-25
First Posted: October 11, 2010    Key Record Dates
Results First Posted: June 21, 2012
Last Update Posted: June 21, 2012
Last Verified: May 2012
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Lisinopril
Nebivolol
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
 Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents