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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01056731
First received: January 25, 2010
Last updated: December 11, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
High Blood Pressure
 Drug: Aliskiren and HCTZ
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • The proportion of patients in whom BP control was achieved at the study end point [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Percentage of patients achieving overall BP, DBP, an SBP control rate at week 4, 8, 12 and 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Change in msSPA and msDBP from baseline to different time points [ Time Frame: 4,8,12 and 16 weeks ] [ Designated as safety issue: No ]
  • Safety of Aliskiren therapy at different time points [ Time Frame: 4,8,12 and 16 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 253
Study Start Date: February 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01056731

Locations
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, Venezuela
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01056731     History of Changes
Other Study ID Numbers: CSPP100AVE01
Study First Received: January 25, 2010
Last Updated: December 11, 2012
Health Authority: Venezuela: Rafael Rangel Institute

Keywords provided by Novartis:
high blood pressure
aliskiren
hydrochlorothiazide
control rate

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013