This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
Novartis Identifier:
First received: January 25, 2010
Last updated: February 21, 2017
Last verified: February 2017
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: 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

Resource links provided by NLM:

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 ]

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 ]
  • 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 ]

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


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01056731

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
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis Identifier: NCT01056731     History of Changes
Other Study ID Numbers: CSPP100AVE01
Study First Received: January 25, 2010
Last Updated: February 21, 2017

Keywords provided by Novartis:
high blood pressure
control rate

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action processed this record on September 18, 2017