A Clinical Study With Aliskiren Alone or in Combination Therapy With Diuretic Hctz in Venezuelan Hypertensive Patients.

High Blood Pressure Clinical Trial

— ANDROMEDA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01056731
• Other study ID #: CSPP100AVE01
• Status: Completed
• Phase: Phase 4
• First received: January 25, 2010
• Last updated: February 21, 2017
• Start date: February 2010
• Est. completion date: October 2011

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• High Blood Pressure
• Hypertension

Intervention

Drug:
• Aliskiren and HCTZ
Aliskiren 150 mg and 300 mg Hydrochlorothiazide 12.5 mg and 25 mg

Locations

Country	Name	City	State
Venezuela	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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients in whom BP control was achieved at the study end point		16 weeks
Secondary	The proportion of patients in whom BP control was reached before the addition of HCTZ (ie, at the pre-HCTZ end point		8 weeks
Secondary	Percentage of patients achieving overall BP, DBP, an SBP control rate at week 4, 8, 12 and 16.		16 weeks
Secondary	Change in msSPA and msDBP from baseline to different time points		4,8,12 and 16 weeks
Secondary	Safety of Aliskiren therapy at different time points		4,8,12 and 16 weeks

External Links

•   Results for CSPP100AVE01 from the Novartis Clinical Trials website