Phase 4 Completed N=641 Randomized Triple-blind Treatment

Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years)

Hypertension

Source: ClinicalTrials.gov NCT01415531 ↗

Enrolled (actual)

641

Serious AEs

1.3%

Results posted

May 2013

Primary outcomePrimary: Trough Seated Diastolic Blood Pressure (DBP) — -5.5; -11.8 mmHG — p=<0.0001

Summary

The purpose of this study is to assess the efficacy, safety, and tolerability of 8 weeks of therapy with nebivolol in comparison to placebo in younger patients 18 - 54 years of age with stage 1 or stage 2 essential hypertension.

Outcome Measures

Outcome	Result	p-value
PRIMARY Trough Seated Diastolic Blood Pressure (DBP)	-5.5; -11.8	<0.0001 sig
SECONDARY Trough Seated Systolic Blood Pressure (SBP)	-5.5; -13.7	—

Eligibility Criteria

Inclusion Criteria

Male and female outpatients, of age 18 - 54 years
Patients diagnosed with stage 1 or stage 2 essential hypertension
Normal physical examination findings and electrocardiogram (ECG) results or abnormal findings judged by the Investigator to be not clinically significant

Exclusion Criteria

Secondary hypertension or severe hypertension
History of Type 1 diabetes mellitus
A medical contraindication to discontinuing a current antihypertensive therapy
Clinically significant respiratory disease that prohibit use of a beta blocker

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01415531). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.