NCT00785512已完成4 期
A Prospective, Randomized, Double-Blind, Placebo Controlled Study of the Long-Term Efficacy of Nebivolol in Hypertensive Patients After Withdrawal of Therapy
Forest Laboratories1 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2008年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Trough Sitting Diastolic Blood Pressure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
1
Active Comparator
Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
干预措施: Nebivolol (Drug)
2
Placebo Comparator
Matching placebo tablets, oral administration
干预措施: Placebo (Drug)
结局指标
主要结局
Trough Sitting Diastolic Blood Pressure
时间窗: From baseline, week 0 (Visit 9) to week 4 (Visit 12)
Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral diastolic blood pressure measured at drug trough.
次要结局
- Trough Sitting Systolic Blood Pressure(From baseline, week 0 (Visit 9) to week 4 (Visit 12))
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
Clinical study to investigate the efficacy, safety, and tolerability of Ketamine HCl PR tablets in patients with chronic non-malignant neuropathic paiChronic non-malignant neuropathic painMedDRA version: 19.0Level: PTClassification code 10029223Term: NeuralgiaSystem Organ Class: 10029205 - Nervous system disordersEUCTR2014-004535-40-DEDevelco Pharma Schweiz AG70
进行中（未招募）
不适用
Clinical study to investigate the efficacy, safety, and tolerability of Ketamine HCl PR tablets in patients with chronic non-malignant neuropathic paiEUCTR2014-004535-40-HUDevelco Pharma Schweiz AG70
招募中
1 期
A randomized, double-blind, prospective clinical study of Weiru Xitong ointment in the treatment of breast hyperplasiaBreast hyperplasiaITMCTR2000003364The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
进行中（未招募）
1 期
Treatment of COVID-19 with allogeneic mesenchymal cells (MSV®).COVID-19MedDRA version: 20.0Level: LLTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 100000004862EUCTR2020-001682-36-ESCITOSPIN S.L.24
Unknown
不适用
A study to assess energy healing using prana as an add-on therapy for Anxiety.CTRI/2017/11/010646World Pranic Healing Foundation India11