A Clinical Study With Aliskiren Alone or in Combination Therapy With Diuretic Hctz in Venezuelan Hypertensive Patients.
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: High Blood Pressure
Intervention: Aliskiren and HCTZ (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s): Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
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.
Clinical Details
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 design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The proportion of patients in whom BP control was achieved at the study end point
Secondary outcome: The proportion of patients in whom BP control was reached before the addition of HCTZ (ie, at the pre-HCTZ end pointPercentage of patients achieving overall BP, DBP, an SBP control rate at week 4, 8, 12 and 16. Change in msSPA and msDBP from baseline to different time points Safety of Aliskiren therapy at different time points
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
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
Locations and Contacts
Investigative Site, BolÃva, Venezuela
Investigative Site, Carabobo, Venezuela
Investigative Site, Caracas, Venezuela
Investigative Site, Edo Zulia, Venezuela
Investigative Site, Estado Monagas, Venezuela
Investigative Site, Falcón, Venezuela
Investigative Site, Maracaibo Estado Zulia, Venezuela
Additional Information
Starting date: February 2010
Last updated: December 11, 2012
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