A Randomized, Double-blind, Parallel-Group Study to Evaluate the Effects of First-Line Treatment With a Free Combination of Nebivolol and Lisinopril Compared With Placebo and the Monotherapy Components on Blood Pressure in Patients With Stage 2 Diastolic Hypertension

Forest Laboratories90 个研究点分布在 1 个国家目标入组 664 人2010年10月

适应症Stage 2 Diastolic Hypertension

干预措施nebivolol and lisinopril (free combination)nebivolol monotherapy lisinopril monotherapy placebo

概览

阶段: 4 期
干预措施: nebivolol and lisinopril (free combination)
疾病 / 适应症: Stage 2 Diastolic Hypertension
发起方: Forest Laboratories
入组人数: 664
试验地点: 90
主要终点: The Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6.
状态: 已完成
最后更新: 13年前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

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).

注册库

clinicaltrials.gov

开始日期

2010年10月

结束日期

2011年6月

最后更新

13年前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Forest Laboratories

责任方

Sponsor

入排标准

入选标准

•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)

排除标准

•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