A 54-week, open label, multi-center study to assess the long-term safety and tolerability of the combination of aliskiren 300 mg/ amlodipine 10 mg in patients with essential hypertensio
- Conditions
- Hypertension
- Registration Number
- EUCTR2006-003629-98-DK
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
1. Outpatients 18 years of age and older.
2. Male or female patients are eligible.
3. For newly diagnosed/untreated patients with essential hypertension defined as
DBP > 90 and < 110 mmHg at Visit 1 and Visit 4.
4. For previously treated patients with essential hypertension defined as DBP = 90
and < 110 mmHg after 2 to 4 weeks of washout (Visits 3 or 4).
5. 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).
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
For full list, please refer to Protocol
1. Previously treated in an aliskiren study that contained the treatment group of the
combination of aliskiren and amlodipine and had been randomized or enrolled
into the active drug treatment period of that study.
2. Severe hypertension (msDBP >110 mmHg and/or msSBP > 180 mmHg)
3. Pregnant or nursing (lactating) women, where pregnancy is defined as a state of
a female after conception and until the termination of gestation, confirmed by a
positive hCG laboratory test (> 5 mIU/ml)
4. Women of child-bearing potential (WOCBP), defined as all women physiologically
capable of becoming pregnant, including women whose career, lifestyle, or sexual
orientation precludes intercourse with a male partner and women whose
partners have been sterilized by vasectomy or other means, UNLESS they meet
the following definition of post-menopausal: 12 months of natural (spontaneous)
amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40
mIU/ml or 6 weeks post surgical blilateral oophorectomy with or without
hysterectomy OR are using one or more of the following acceptable methods of
contraception such as surgical sterilization (e.g., bilateral tubal ligation) or
hormonal contraception (implantable, patch, oral). Reliable contraception should
be maintained throughout the study and for 7 days after study medication
discontinuation.
5. History or evidence of a secondary form of hypertension
6. Any history of hypertensive encephalopathy or cerebrovascular accident, or
history within 12 months from visit 1 for transient ischemic attack (TIA),
myocardial infarction, coronary bypass surgery, or any percutaneous coronary
intervention (PCI).
7. Previous or current diagnosis of heart failure (NYHA Class III-IV).
8. Serum potassium > 5.3 mEq/L (mmol/L) at Visit 1.
9. Patients with Type 1 or Type 2 diabetes mellitus who are not well controlled
based on the investigator's clinical judgment. Patients with diabetes mellitus
enrolled in this study should be well controlled. It is recommended that patients
currently being treated for diabetes mellitus be on a stable dose of antidiabetic
medication for at least 4 weeks prior Visit 1.
10. Current angina pectoris requiring pharmacological therapy except for nitrates.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the long-term (6 month and 12 month) safety of the combinations of aliskiren 300mg/ amlodipine 10 mg in patients with essential hypertension ;Secondary Objective: To assess the long-term blood pressure lowering efficacy of the combination of aliskiren/amlodipine in patients with essential hypertension (msDBP > 90 mmHg and <110 mmHg)<br>To evaluate the proportion of patients achieving the blood pressure control target of < 140/90.<br>To evaluate the proportion of patients achieving a response in msDBP (msDBP < 90mmHG or = 10mmHg) decrease from baseline;Primary end point(s): The primary assessment for safety is the reporting of any adverse events and serious adverse events (SAE) including death. Adverse events will be assessed, on overall, by primary system organ class, by preferred term, by maximum severity, by relationship to the trial treatment, and by discontinuation due to adverse events.
- Secondary Outcome Measures
Name Time Method