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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

January 25, 2010
December 11, 2012
February 2010
October 2011   (final data collection date for primary outcome measure)
The proportion of patients in whom BP control was achieved at the study end point [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01056731 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Clinical Study With Aliskiren Alone or in Combination Therapy With Diuretic Hctz in Venezuelan Hypertensive Patients.
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.
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
High Blood Pressure
Drug: Aliskiren and HCTZ
Aliskiren 150 mg and 300 mg Hydrochlorothiazide 12.5 mg and 25 mg
Experimental: Aliskiren and Aliskiren_HCTZ
aliskiren 150 mg and 300 mg Hydrochlorothiazide 12.5 mg 25 mg
Intervention: Drug: Aliskiren and HCTZ
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
253
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Venezuela
 
NCT01056731
CSPP100AVE01
Yes
Novartis
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
December 2012

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