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

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ClinicalTrials.gov Identifier: NCT01056731

Recruitment Status : Completed

First Posted : January 26, 2010

Last Update Posted : February 23, 2017

Sponsor:

Information provided by (Responsible Party):

Novartis

Tracking Information

First Submitted Date ^ICMJE

January 25, 2010

First Posted Date ^ICMJE

January 26, 2010

Last Update Posted Date

February 23, 2017

Study Start Date ^ICMJE

February 2010

Actual Primary Completion Date

October 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The proportion of patients in whom BP control was achieved at the study end point [ Time Frame: 16 weeks ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01056731 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The proportion of patients in whom BP control was reached before the addition of HCTZ (ie, at the pre-HCTZ end point [ Time Frame: 8 weeks ]
Percentage of patients achieving overall BP, DBP, an SBP control rate at week 4, 8, 12 and 16. [ Time Frame: 16 weeks ]
Change in msSPA and msDBP from baseline to different time points [ Time Frame: 4,8,12 and 16 weeks ]
Safety of Aliskiren therapy at different time points [ Time Frame: 4,8,12 and 16 weeks ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

High Blood Pressure

Intervention ^ICMJE

Drug: Aliskiren and HCTZ

Aliskiren 150 mg and 300 mg Hydrochlorothiazide 12.5 mg and 25 mg

Study Arms

Experimental: Aliskiren and Aliskiren_HCTZ

aliskiren 150 mg and 300 mg Hydrochlorothiazide 12.5 mg 25 mg

Intervention: Drug: Aliskiren and HCTZ

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

253

Original Estimated Enrollment ^ICMJE

255

Actual Study Completion Date

October 2011

Actual Primary Completion Date

October 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 85 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Venezuela

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01056731

Other Study ID Numbers ^ICMJE

CSPP100AVE01

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Novartis

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

PRS Account

Novartis

Verification Date

February 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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