Phase 4
Completed N=664
Efficacy and Safety Study to Evaluate Combination Therapy With Nebivolol and Lisinopril vs. Placebo and Monotherapy in Patients With Stage 2 Diastolic Hypertension
Stage 2 Diastolic Hypertension
Source: ClinicalTrials.gov NCT01218100 ↗
Enrolled (actual)
664
Serious AEs
1.7%
Results posted
Jun 2012
Primary outcomePrimary: The Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6. — -8.0; -17.2; -13.3; -12.0 mm HG
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6. |
-8.0; -17.2; -13.3; -12.0 | — |
| SECONDARY The Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6. |
-9.9; -19.2; -14.4; -16.1 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01218100). 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.