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CompletedNCT00294710Updated Nov 8, 2011

A Clinical Study to Compare Long-term Efficacy and Safety of an Aliskiren Based Regimen to a Hydrochlorothiazide Based Treatment Regimen With Optional Addition of Amlodipine

A Phase 3 interventional study of Aliskiren in Hypertension, sponsored by Novartis. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-11-08.

Sponsored by Novartis · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
976
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This study is designed to compare the long-term efficacy and safety of an aliskiren based regimen to an HCTZ based treatment regimen with optional addition of amlodipine in patients with essential hypertension

02

Conditions studied

  • Hypertension

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Keywords

  • Hypertension, aliskiren, hydrochlorothiazide, amlodipine
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 976 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with essential hypertension

Exclusion criteria

Exclusion Criteria:

  • Severe hypertension
  • History or evidence of a secondary form of hypertension
  • History of myocardial infarction.
  • Other protocol-defined inclusion exclusion criteria also apply.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
976 participants (actual)

Interventions

  • DrugAliskiren
06

What researchers measure

Primary outcomes

  1. Change from baseline in diastolic blood pressure after 52 weeks

Secondary outcomes

  1. Change from baseline in systolic and diastolic blood pressure after 52 weeks

  2. Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 52 weeks

  3. Achieve blood pressure control target of < 140/90 mmHg after 12 weeks

07

Study locations

2 sites
  • Novartis
    East Hanover, New Jersey 07936, United States
  • Investigative Centers, Germany
08

References and documents

Publications

  • Schmieder RE, Philipp T, Guerediaga J, Gorostidi M, Smith B, Weissbach N, Maboudian M, Botha J, van Ingen H. Long-term antihypertensive efficacy and safety of the oral direct renin inhibitor aliskiren: a 12-month randomized, double-blind comparator trial with hydrochlorothiazide. Circulation. 2009 Jan 27;119(3):417-25. doi: 10.1161/CIRCULATIONAHA.107.750745. Epub 2009 Jan 12. PubMed 19139391 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00294710
Lead sponsor
Novartis
Responsible party
Sponsor
First posted
Feb 22, 2006
Start date
Mar 2005
Primary completion
Jul 2006
Completion
Jul 2006
Last update
Nov 8, 2011

Study contacts

Novartis Pharmaceuticals
principal investigator · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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