Evaluation of the Long-term Safety and Tolerability of Metoprolol Versus Nebivolol in Patients With Hypertension

NCT00142584 | Completed Phase 3 Results

• 1 other identifier: NEB324
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate long-term safety,tolerability and blood pressure effects of metoprolol versus nebivolol in patients with hypertension. These drugs may be given alone or in combination with other drugs that are commonly used in the treatment of hypertension

Conditions

Hypertension

Keywords

safety and tolerability study; hypertension; beta-blockers

Outcome Measures

Primary Outcomes (1)

• Change in Average Sitting Diastolic Blood Pressure (DBP) Taken at Trough at the End of Treatment Compared to Baseline

  The primary efficacy parameter was the change in the average trough sitting DBP at the end of treatment (Visit 10 or Early Termination) compared with baseline (baseline was defined as the baseline visit in Study NEB 310 \[NCT00145210\]).

  Through study duration (approximately 18 months)

Secondary Outcomes (2)

• Change From Baseline in Mean Trough Sitting Diastolic Blood Pressure (DBP) at Each Study Visit (Visits 1 Through 9) Compared to Baseline

  Through study completion (approximately 18 months)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  Through study completion (approximately 18 months)

Study Arms (2)

1-NEB

EXPERIMENTAL

Nebivolol

Drug: Nebivolol (NEB)

2-MET

ACTIVE COMPARATOR

Metoprolol

Drug: Metoprolol (MET)

Interventions

Nebivolol (NEB) DRUG

Patients randomized to nebivolol will initiate therapy with nebivolol 5 mg once daily for 4 weeks.

1-NEB

Metoprolol (MET) DRUG

Patients randomized to metoprolol will initiate therapy with 100 mg once daily for 4 weeks.

2-MET

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completion of previous nebivolol study
• Stage 1-2 Hypertension (HTN) at baseline of first study

You may not qualify if:

• Recent myocardial infarction or stroke
• Contraindications to beta blocker therapy

Sponsors & Collaborators

• Mylan Bertek Pharmaceuticals: lead

Study Sites (1)

Mylan Pharmaceuticals Inc.

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Nebivolol; Metoprolol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenoxypropanolamines; Propanolamines; Propanols

Results Point of Contact

• Title: M. Rachel Kirker, PhD, Director, Clinical Oversight & Inspection Readiness
• Organization: Viatris Inc

rachel.kirker@viatris.com

724-485-6170

Study Officials

• Betty S Riggs, MD, MBA

  Mylan Pharmaceuticals Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 2, 2005
• Study Start: August 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: March 15, 2022
• Results First Posted: March 15, 2022

Record last verified: 2022-02

Locations

US (1)