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

February 21, 2017 updated by: Novartis

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

253

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Venezuela
      • 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
        • Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Aliskiren and Aliskiren_HCTZ
aliskiren 150 mg and 300 mg Hydrochlorothiazide 12.5 mg 25 mg
Drug: Aliskiren and HCTZ
Aliskiren 150 mg and 300 mg Hydrochlorothiazide 12.5 mg and 25 mg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
8 weeks
Percentage of patients achieving overall BP, DBP, an SBP control rate at week 4, 8, 12 and 16.
Time Frame: 16 weeks
16 weeks
Change in msSPA and msDBP from baseline to different time points
Time Frame: 4,8,12 and 16 weeks
4,8,12 and 16 weeks
Safety of Aliskiren therapy at different time points
Time Frame: 4,8,12 and 16 weeks
4,8,12 and 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (ACTUAL)

October 1, 2011

Study Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

January 25, 2010

First Submitted That Met QC Criteria

January 25, 2010

First Posted (ESTIMATE)

January 26, 2010

Study Record Updates

Last Update Posted (ACTUAL)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 21, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPP100AVE01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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