A 54-week, open-label, multicenter study to assess the long-term safety and tolerability of the combination of aliskiren 300mg/ valsartan 320 mg in patients with essential hypertension.
- Conditions
- Hypertension
- Registration Number
- EUCTR2006-002621-23-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 834
- Outpatients 18 years of age and older.
- Male or female patients are eligible.
- For newly diagnosed/untreated patients with essential hypertension defined as
DBP > 90 and <110 mmHg at Visit 1 and Visit 2.
- 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).
- 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
- Previously treated in an aliskiren study that contained the treatment group of the
combination of aliskiren and valsartan and had been randomized or enrolled into
the active drug treatment period of that study.
- Severe hypertension (msDBP >110 mmHg and/or msSBP > 180 mmHg)
- Pregnant or nursing (lactating) women
- Women of child-bearing potential (WOCBP)
- History or evidence of a secondary form of hypertension
- 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).
- Previous or current diagnosis of heart failure (NYHA Class III –IV)
- Serum potassium > 5.3 mEq/L (mmol/L) at Visit 1.
- 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.
- Current angina pectoris requiring pharmacological therapy except for nitrates.
- Second or third degree heart block without a pacemaker.
- Atrial fibrillation or atrial flutter at Visit 1, or potentially life-threatening arrhythmia
during the 12 months prior to Visit 1.
- Any medication, surgical or medical condition which might significantly alter the
absorption, distribution, metabolism, or excretion of medications including, but not
limited to any of the following:
• History of major gastrointestinal tract surgery such as gastrectomy,
gastroenterostomy, or bowel resection.
• History of active inflammatory bowel disease during the 12 months prior to Visit 1.
• Currently active gastritis, duodenal or gastric ulcers, or history of gastrointestinal
bleeding during the 3 months prior to Visit 1.
• Evidence of hepatic disease as determined by any one of the following: ALT or AST
values exceeding 3x ULN at Visit 1, a history of hepatic encephalopathy, a history
of esophageal varices, or a history of portocaval shunt.
• Evidence of renal impairment as determined by any one of the following: serum
creatinine > 1.5x ULN at Visit 1, a history of dialysis, or a history of nephrotic
syndrome.
• Current treatment with cholestyramine or colestipol resins.
- History of hypersensitivity to any of the medications or drugs belonging to the
similar therapeutic class (ARB's, ACE-I, thiazide diuretics, or other sulfonamide
derived drugs) as the study drugs.
- History of malignancy of any organ system, treated or untreated, within the past 5
years whether or not there is evidence of local recurrence or metastases, with the
exception of localized basal cell carcinoma of the skin.
- History or evidence of drug or alcohol abuse within the last 12 months.
- Any surgical or medical condition which in the opinion of the investigator may place
the patient at higher risk from his/her participation in the study, or is likely to
prevent the patient from complying with the requirements of the study or
completing the study.
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5
halflives of enrollment, whichever is longer.
- If subject is expected to continue or start any medication listed in secti
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 combination of aliskiren 300 mg/ valsartan 320 mg in patients with essential hypertension (msDBP > 90 mmHg and < 110 mmHg.;Secondary Objective: - To assess the long-term blood pressure lowering efficacy of the combination of <br> aliskiren/valsartan in patients with essential hypertension (msDBP > 90 mmHg and <br> <110 mmHg) <br>- To evaluate the proportion of patients achieving the blood pressure control target <br> of < 140/90 mmHg at the end of study.<br><br>Exploratory objective(s)<br>1. To explore the effect of long-term treatment with the combination of aliskiren <br> 300 mg/valsartan 320 mg on plasma renin activity (PRA), plasma aldosterone and <br> plasma renin concentration (PRC).;Primary end point(s): Long term safety
- Secondary Outcome Measures
Name Time Method