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Nebivolol in Patients With Systolic Stage 2 Hypertension (NEB-MD-20)

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Forest Laboratories

Status and phase

Completed
Phase 4

Conditions

Hypertension

Treatments

Drug: Nebivolol
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01057251
NEB-MD-20

Details and patient eligibility

About

The primary object of this study is to evaluate the efficacy and safety of 6 weeks of nebivolol monotherapy compared with placebo in patients with systolic stage 2 hypertension.

Enrollment

433 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • male of female, 18 to 64 years of age at screening
  • mean seated heart rate at least 60 bpm
  • diagnosed systolic stage 2 hypertension
  • unremarkable physical exam findings

Exclusion criteria

  • high risk due to secondary hypertension or former stage 3 hypertension by JNC6
  • concurrent conditions (reno, cardiovascular, obesity, thyroid, etc)
  • currently taking medication that cannot be stopped during the course of the study
  • participating other clinical trials
  • member of the study center personnel
  • documented drug abuse
  • contra indication to beta blocker
  • abnormal lab finding
  • poor compliance
  • other conditions judged by investigator that is not suitable for the study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

433 participants in 2 patient groups, including a placebo group

1
Experimental group
Treatment:
Drug: Nebivolol
2
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

36

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Data sourced from clinicaltrials.gov

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