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Completed

NCT Number: NCT01056731

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

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.

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Key information

Conditions

High Blood Pressure Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Investigative Site, Bolíva, Venezuela

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aliskiren and HCTZ

Drug

Aliskiren 150 mg and 300 mg Hydrochlorothiazide 12.5 mg and 25 mg

Primary outcomes

  1. The proportion of patients in whom BP control was achieved at the study end point

    Time frame: 16 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Acronym: ANDROMEDA

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 26, 2010
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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