Phase 4
Completed N=207
A Study on the Long-term Efficacy of Nebivolol After Withdrawal of Therapy
Source: ClinicalTrials.gov NCT00785512 ↗Enrolled (actual)
207
Serious AEs
0.4%
Results posted
Sep 2010
Primary outcomePrimary: Trough Sitting Diastolic Blood Pressure — 81.3; 81.1; 1.8; 7.7 mm HG
Summary
This study will evaluate the long-term efficacy of nebivolol monotherapy in patients with stage 1 or stage 2 hypertension after the withdrawal of active medication.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough Sitting Diastolic Blood Pressure |
81.3; 81.1; 1.8; 7.7 | — |
| SECONDARY Trough Sitting Systolic Blood Pressure |
134.1; 134.4; 3.5; 7.6 | — |
Eligibility Criteria
Inclusion Criteria
- male and female outpatients 18 to 79 years of age
- Females must be post-menopausal, or not pregnant and using an approved contraceptive regimen
- meet criteria for stage I or II hypertension
- currently not treated, or being treated with no more than two anti-hypertensive medications
Exclusion Criteria
- type 1 or type 2 diabetes
- secondary hypertension
- evidence of other concurrent disease or conditions that might interfere with the conduct of the study
- treatment with any investigational study drug within 30 days of Screening (Visit 1)
- have a history of hypersensitivity to nebivolol or other β-blockers
Data sourced from ClinicalTrials.gov (NCT00785512). 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.