The Primary objective is 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.
ID
Source
Brief title
Condition
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The assessment of safety will be based primarily on the frequency of adverse
events, laboratory abnormalities, and serious adverse events suspected by the
investigators to be related to study medications.
Secondary outcome
n.a.
Background summary
The Renin-angiotensin system (RAS) plays a major role in the regulation of
arterial blood pressure and the pathogenesis of hypertension. Aliskiren is a
new dug from a new class of antihypertensiva, the renin inhibitors. This renin
inhibitor blocks the RAAS system at first level so angiotensin is no longer
coverted into angiotensin I.
So far, aliskiren has been studied in more than 30 clinical studies both in
healty people and in patients with hypertension or other heart and renal
diseases. Valsartan belongs to a class of drugs called 'Angiotensin Rceptor
Blockers (ARBs)'. It is an approved drug and available in may countries of the
world. It has been studied extensively in clinical trials for treating patients
with hypertension and has been shown to be generally well tolerated.
Hydrochloorthiazide (HCTZ) belongs to a class of drug called thiazide
diuretics. It is an approved drug and available in may countries of the world.
HCTZ works by affecting the kidney and increases elimination of certain
minerals such as sodium and chloride and water which lowers blood pressure.
Study objective
The Primary objective is 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.
Study design
This is an open label, phase III study. Each patient will have a screening
visit. Treated patients will then enter the wash-out period of maximal 4 weeks.
If the patient meets the in- and exclusioncriteria the patient will be treated
with the combination aliskiren 150mg/ valsartan 160mg for 2 weeks. Subsequently
the patient will be treated with the combination aliskiren 300mg/ valsartan 320
mg for 52 weeks. Starting from Visit 8, patients whose msSBP is * 140 mmHg and/
or msDBP * 90 mmHg for two consecutive visits may have hydrochlorothiazide
(HCTZ) 12.5 mg added. If the patient*s msSBP remains * 140 mmHg and/ or msDBP
remains * 90 mmHg after adding HCTZ 12.5, the dose of HCTZ can be increased to
25 mg.
Intervention
At Visit 4, all patients that meet study entry criteria will begin the initial
treatment of aliskiren 150 mg / valsartan 160 mg for two weeks.
At Visit 5 (Day 14), the dose of the study medication will be force-titrated to
aliskiren 300mg/valsartan 320mg.
Starting from Visit 8, patients whose msSBP is * 140 mmHg and/ or msDBP * 90
mmHg for two consecutive visits may have hydrochlorothiazide (HCTZ) 12.5 mg
added. If the patient*s msSBP remains * 140 mmHg and/ or msDBP remains * 90
mmHg after adding HCTZ 12.5, the dose of HCTZ can be increased to 25 mg.
Study burden and risks
It cannot be guaranteed that the health of each patient will improve by
participating in this study. Patients will be checked up regularly during this
study and medication will be dispensed at no costs. The results of this study
might help other patients with hypertension.
Possible discomforts of the study are: visiting the centre 13 times for
bloodpressure and pulse measurements. One EKG will be made and blood will be
drawn during 11 visits containing about 6-7 teaspoons. Blooddraws can cause
some discomforts or some bruising. In rare cases an inflammation may occur.
Raapopseweg 1
6824 DP
Nederland
Raapopseweg 1
6824 DP
Nederland
Listed location countries
Age
Inclusion criteria
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 2.
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).
Exclusion criteria
1. Severe hypertension (msDBP >110 mmHg and/or msSBP > 180 mmHg)
2. History or evidence of a secondary form of hypertension
3. 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).
4. Previous or current diagnosis of heart failure (NYHA Class III-IV).
5. 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.
6. Current angina pectoris requiring pharmacological therapy except for nitrates.
7. Atrial fibrillation or atrial flutter at Visit 1, or potentially life-threatening arrhythmia during the 12 months prior to Visit 1
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-002621-23-NL |
| CCMO | NL13877.072.06 |