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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01056731
Recruitment Status : Completed
First Posted : January 26, 2010
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
High Blood Pressure Drug: Aliskiren and HCTZ Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 253 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

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

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

Secondary Outcome Measures :
  1. 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 ]
  2. Percentage of patients achieving overall BP, DBP, an SBP control rate at week 4, 8, 12 and 16. [ Time Frame: 16 weeks ]
  3. Change in msSPA and msDBP from baseline to different time points [ Time Frame: 4,8,12 and 16 weeks ]
  4. Safety of Aliskiren therapy at different time points [ Time Frame: 4,8,12 and 16 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01056731

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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
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Identifier: NCT01056731    
Other Study ID Numbers: CSPP100AVE01
First Posted: January 26, 2010    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Keywords provided by Novartis:
high blood pressure
control rate
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases