An Eight Week Randomized, Double-Blind, Double-Dummy Study Comparing a Fixed Dose Combination of Telmisartan 80mg Plus Hydrochlorothiazide 12.5mg to Telmisartan 80mg in Patients Who Fail to Respond Adequately to Treatment With Telmisartan 80mg.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 345
- 试验地点
- 9
- 主要终点
- The primary efficacy variable is change from baseline in seated DBP at trough (24 hours post-dosing) after eight weeks of randomized treatment or at last trough observation during the double-blind phase (i.e. last trough observation carried forward).
研究概览
简要总结
To demonstrate that a fixed dose combination of telmisartan 80 mg plus HCTZ 12.5 mg is superior to telmisartan 80 mg alone in patients, who fail to respond adequately to telmisartan 80 mg monotherapy, in lowering seated trough diastolic blood pressure after eight weeks of treatment.
详细描述
This is a multi-centre, prospective, randomized, double-blind, parallel-group study in approximately 244 patients with a history of mild-to-moderate hypertensive who have been shown not to respond to telmisartan monotherapy.
All patients will enter a one-week screening phase prior to starting the eight-week open-label T80 mg period. At the end of four weeks, only patients who fail to respond to T80 mg (DBP >= 90 mm Hg) will continue the treatment with T80 mg for another four weeks. At the end of eight weeks, only patients who fail to respond to T80 mg (DBP >= 90 mm Hg) will be randomized, double-blind, to receive either T80 mg alone or the fixed dose combination of T80 mg plus HCTZ 12.5 mg for eight weeks. Seated BP will be taken 24 hours post-dose at each visit. Labs, ECG, and physical examination will be done at screening, at baseline and at the final visit.
Study Hypothesis:
The primary objective of the study, showing that fixed dose combination is superior to telmisartan 80 mg alone will be tested using the hypotheses given below.
H0: u T80/H12.5 - uT80 = 0 mm Hg versus H1: uT80/H12.5 - uT80 not equal 0 mm Hg, where uT80/H12.5 anduT80 represent the average reduction from baseline (Visit 4) in trough seated DBP for the fixed dose combination and telmisartan 80 mg, respectively.
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of mild-to-moderate hypertension defined by a mean seated DBP >=95 and <= 109 mmHg before inclusion in the open-label phase
- •Patients who fail to respond adequately to telmisartan monotherapy (mean seated DBP >= 90 mmHg)
- •Participants between 18 and 80 years of age
- •Ability to provide written informed consent
排除标准
- •Patients taking more than three anti-hypertensive medications at the screening visit.
- •Pre-menopausal women (last menstruation 1 year prior to start of screening):
- •Who are not surgically sterile (hysterectomy, tubal ligation)
- •Who are NOT practicing acceptable means of birth control or who do NOT plan to continue using an acceptable method throughout the study (acceptable methods of birth control include IUD, oral, implantable or injectable contraceptives)
- •Who has a positive urine pregnancy test at screening (Visit 1)
- •Who is nursing
- •Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
- •SGPT(ALT) or SGOT(AST) greater than two times the upper limit of normal
- •Serum creatinine > 3.0 mg/dL (or 265 mol/L) or creatinine clearance < 0.6 ml/sec
- •Clinically relevant hypokalaemia or hyperkalaemia
- •Uncorrected volume depletion
- •Uncorrected sodium depletion
- •Primary aldosteronism
- •Hereditary fructose intolerance
- •Biliary obstructive disorders, cholestasis or moderate to severe hepatic insufficiency
- •Known or suspected secondary hypertension
- •Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; post-renal transplant patients, presence of only one functioning kidney
- •Congestive heart failure (NYHA functional class CHF III-IV)
- •Unstable angina within the past three months
- •Stroke within the past six months
- •Myocardial infarction or cardiac surgery within the past three months
- •PTCA within the past three months
结局指标
主要结局
The primary efficacy variable is change from baseline in seated DBP at trough (24 hours post-dosing) after eight weeks of randomized treatment or at last trough observation during the double-blind phase (i.e. last trough observation carried forward).
次要结局
- Change from baseline in seated SBP, standing DBP and SBP at trough after eight weeks of randomized treatment or at last trough observation during the double-blind phase. The percentage of patients responding to the treatment. Safety.