Phase III Study Evaluating the Efficacy and Safety of Olmesartan Medoxomil/Hydrochlorothiazide 40/12.5 mg Combination Therapy Versus Olmesartan Medoxomil 40 mg Monotherapy in Patients With Essential Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,004
- 主要终点
- dBP Change After 8 Weeks Phase A
研究概览
简要总结
The primary objective of this study was to assess the anti-hypertensive effect of OM/HCTZ 40/12.5 mg combination therapy compared to OM 40 mg monotherapy in lowering sitting diastolic BP in hypertensive patients after 8 weeks of double-blind treatment.
The study consisted of two sequential phases of 8 weeks duration each:
During the first phase, OM 40 mg monotherapy was compared with OM/HCTZ 40/12.5 mg in order to evaluate the additional benefit of OM/HCTZ 40/12.5 mg in the treatment of essential moderate to severe hypertension.
During the second phase, patients whose BP proved to be insufficiently controlled by the OM 40 mg monotherapy were to start OM/HCTZ 40/12.5 mg combination therapy while patients whose BP proved to be insufficiently controlled by the OM/HCTZ 40/12.5 mg combination were to be up-titrated to the OM/HCTZ 40/25 mg combination to evaluate the additional benefit of the up-titrated combination.
The study was be conducted by qualified and experienced personnel with adherence to GCP, current guidelines on the design of studies in hypertension, the applicable regulatory requirements and the ethical principles based on the Declaration of Helsinki.
详细描述
Methodology:
After the signature of the informed consent, patients were screened for eligibility and eligible patients entered into a pre-randomisation period consisting of a taper-off phase of approximately 1-2 weeks (during which patients treated for hypertension were to discontinue their antihypertensive therapy) followed by a 2-week single-blind placebo run-in phase (Visit 1). After conclusion of the placebo run-in phase (Visit 2), eligible patients were randomised to the double-blind active treatment period which consisted of two phases:
First double-blind treatment phase (Phase A, from Randomisation to Week 8):
Eligible patients with mean sitting sBP ≥ 160 and ≤ 200 mmHg and dBP ≥ 100 mmHg and ≤ 120 mmHg were randomised in a 1:2 ratio to receive either OM 40 mg or OM/HCTZ 40/12.5 mg for a total of 8 weeks of treatment (Phase A). Study visits were held after 4 and 8 weeks of double-blind active treatment (Visit 3 and 4, respectively). After 8 weeks (Visit 4), patients reaching the BP goal of < 140/90 mmHg or < 130/80 mmHg for diabetics were considered as responders. All patients (responders and non-responders) then entered into the titration phase of the study (Phase B):
Second double-blind treatment phase/titration phase (Phase B, from Week 8 to Week 16):
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of essential hypertension, either treatment-naive or including currently on anti-hypertensive medication (in Italy only treatment naive patients) in whom it is medically justifiable to withdraw treatment , and who are likely to meet the required BP inclusion criteria at randomisation:
- •Mean sitting dBP ≥ 100 mmHg and ≤ 120 mmHg.
- •Mean sitting sBP ≥ 160 mmHg and ≤ 200 mmHg.
排除标准
- •Mean sitting sBP values > 200 mmHg and/or dBP > 120 mmHg.
- •Pregnant or nursing women.
- •Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the tested medication, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological, oncological, neurological, and psychiatric diseases. The same applies for immunocompromised and/or neutropenic patients.
- •Patients with secondary hypertension of any aetiology such as renal disease, pheochromocytoma, or Cushing's syndrome.
研究组 & 干预措施
OM/HCTZ 40/12.5
Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets.
干预措施: OM/HCTZ 40/12.5 (Drug)
OM 40
Olmesartanmedoxomil (OM)40 mg tablets.
干预措施: OM 40 (Drug)
结局指标
主要结局
dBP Change After 8 Weeks Phase A
时间窗: Eight weeks
Reduction in Mean Trough Sitting dBP (mmHg) from Baseline (Week 0) to Week 8
sBP Change After 8 Weeks Phase A
时间窗: Eight weeks
Reduction in Mean Trough Sitting sBP (mmHg) from Baseline (Week 0) to Week 8
次要结局
- sBP Change After 8 Weeks Phase B(Eight weeks)
- dBP Change After 8 Weeks Phase B(Eight weeks)