Clinical trial NCT01056731: A Clinical Study With Aliskiren Alone or in Combination Therapy With Diuretic Hctz in Venezuelan Hypertensive Patients.
Official title: A 16-week, Prospective, Open Label, Multicenter Study to Evaluate the Effectiveness and Safety of Rasilez® (Aliskiren) Monotherapy or in Addition With Hydrochlorothiazide 12.5 mg or 25 mg in Patients With Hypertension Stage I and II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: High Blood Pressure
Keywords: high blood pressure
aliskiren
hydrochlorothiazide
control rate
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-01-26
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, not controlled, sequential, dose escalation study of 16 weeks' duration. The study is composed of two periods: a 0-2 week optional wash-out period depending on previous antihypertensive treatment(s), followed by a 16-week open-label active treatment period. Patients will be evaluated every 4 weeks during period 2. Treatment will start with Aliskiren 150 mg with dose titration to Aliskiren 300 mg, and addition of HCTZ 12,5 mg and 25 if control of BP is not achieved (\< 140/90 mmHg or 130/ 80 mmHg in diabetics patients). All patients who have reached their BP target will be considered as having met the primary endpoint and this visit will be considered as the final visit.


Eligibility criteria: Inclusion Criteria:

* Outpatients, with essential hypertension, stage I-II, naïve or not controlled with monotherapy.

Exclusion Criteria:

* BP\> 180/110 mmHg
* Pregnant or nursing women
* Hypertensive encephalopathy or cerebrovascular accident, transient ischemic - cerebral attack, myocardial infarction, unstable angina, coronary bypass surgery, percutaneous coronary intervention within 6 month
* K \<3.5 mEq/L or ≥ 5 mEq/L
* Renal impairment
* Hypersensitivity to HCTZ or Aliskiren or angioedema due to ACE-I or ARB
* Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: The proportion of patients in whom BP control was achieved at the study end point
timeFrame: 16 weeks
Secondary outcomes:
measure: The proportion of patients in whom BP control was reached before the addition of HCTZ (ie, at the pre-HCTZ end point
timeFrame: 8 weeks
measure: Percentage of patients achieving overall BP, DBP, an SBP control rate at week 4, 8, 12 and 16.
timeFrame: 16 weeks
measure: Change in msSPA and msDBP from baseline to different time points
timeFrame: 4,8,12 and 16 weeks
measure: Safety of Aliskiren therapy at different time points
timeFrame: 4,8,12 and 16 weeks
Other outcomes:
Locations:
city: Bolíva
country: Venezuela
facility: Investigative Site
city: Carabobo
country: Venezuela
facility: Investigative Site
city: Caracas
country: Venezuela
facility: Investigative Site
city: Edo Zulia
country: Venezuela
facility: Investigative Site
city: Estado Monagas
country: Venezuela
facility: Investigative Site
city: Falcón
country: Venezuela
facility: Investigative Site
city: Maracaibo Estado Zulia
country: Venezuela
facility: Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: