CClinicalTrials.gg
CompletedNCT00219193Updated Feb 7, 2017

A Clinical Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren and Valsartan in Hypertensive Non Responders Patients

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 and older. Per ClinicalTrials.gov, last updated 2017-02-07.

Sponsored by Novartis · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
641
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

To evaluate the blood pressure lowering effect and safety of the triple combination aliskiren / valsartan / HCTZ (300/320/25 mg) in patients with essential hypertension not adequately responsive to HCTZ 25 mg

02

Conditions studied

  • Hypertension

Browse trials for

Keywords

  • Hypertension, aliskiren, blood pressure, valsartan, HCTZ
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 964 are open to participants now.

This study's enrollment of 641 is above the median of 90 across 4,994 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 and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with essential hypertension
  • Patients who are eligible and able to participate in the study

Exclusion criteria

Exclusion Criteria

  • Severe hypertension
  • History or evidence of a secondary form of hypertension

Other protocol-defined exclusion criteria may apply.

05

Study design

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

Interventions

  • Drugaliskiren
06

What researchers measure

Primary outcomes

  1. Change from baseline in diastolic blood pressure after 8 weeks

Secondary outcomes

  1. Change from baseline in systolic and diastolic blood pressure after 4 weeks and 8 weeks

  2. Change from baseline in standing blood pressure after 4 weeks and 8 weeks

  3. Achieve blood pressure control target of < 140/90 mmHg after 8 weeks

07

Study locations

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

References and documents

Publications

  • Geiger H, Barranco E, Gorostidi M, Taylor A, Zhang X, Xiang Z, Zhang J. Combination therapy with various combinations of aliskiren, valsartan, and hydrochlorothiazide in hypertensive patients not adequately responsive to hydrochlorothiazide alone. J Clin Hypertens (Greenwich). 2009 Jun;11(6):324-32. doi: 10.1111/j.1751-7176.2009.00114.x. PubMed 19527323 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00219193
Lead sponsor
Novartis
Responsible party
Sponsor
First posted
Sep 22, 2005
Start date
Oct 2005
Primary completion
Jan 2007
Completion
Jan 2007
Last update
Feb 7, 2017

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion