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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 point

Percentage 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, Bolíva, 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

Page last updated: August 23, 2015

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