A twenty six-week, randomized, double-blind, parallel group, multicenter, active controlled, dose titration study to evaluate the efficacy and safety of aliskiren compared to HCTZ with the optional addition of amlodipine, followed by a second twenty six weeks of blinded treatment in patients with essential hypertensio
- Conditions
- Hypertension
- Registration Number
- EUCTR2004-004015-38-ES
- Lead Sponsor
- ovartis Farmacéutica, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1100
1.Outpatients 18 years of age and older.
2.Patients with essential hypertension. Patients must have a MSDBP >= 90 mmHg and < 110 mmHg at the visit immediately prior to Visit 3 (i.e. Visit 2 or optional Visit 201).
3.Male or female patients are eligible. Female patients must be either post-menopausal for one year, surgically sterile, or using effective contraceptive methods such as oral contraceptives, barrier method with spermicide or an intrauterine device.
4.Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).
To be eligible for randomization at Visit 3, Patients must also meet the following blood pressure criteria:
5.Patients must have a MSDBP >= 95 mmHg and < 110 mmHg at Visit 3 (Day 1).
6.Patients must have an absolute difference <= 10 mmHg in their MSDBP from Visit 2 to Visit 3 (or from optional Visit 201 to Visit 3).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.History of severe hypertension (MSDBP >= 110 mmHg and/or MSSBP >= 180 mmHg)
2.History or evidence of a secondary form of hypertension
3.Known Keith-Wagener grade III or IV hypertensive retinopathy
4.History of hypertensive encephalopathy or cerebrovascular accident
5.Transient ischemic cerebral attack, coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1
6.Current diagnosis of heart failure (NYHA Class II-IV)
7.History of myocardial infarction
8.Current angina pectoris requiring pharmacological therapy (other than stable doses of oral or topical nitrates)
9.Second or third degree heart block without a pacemaker
10.Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia
11.Clinically significant valvular heart disease
12.Type 1 or Type 2 diabetes mellitus with fasting glycosylated hemoglobin (HbA1c) > 9% or microalbuminuria or proteinuria at Visit 1
13.Serum sodium less than the lower limit of normal, serum potassium less than 3.5 mEq/L (corresponding to 3.5 mmol/L) or >= 5.5 mEq/L (corresponding to 5.5 mmol/L), or dehydration at Visit 1
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method