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CompletedNCT00171535Updated Nov 8, 2011

Efficacy and Safety of Valsartan/Amlodipine Combination in Patients With Severe Hypertension

A Phase 3 interventional study of valsartan/amlodipine in Hypertension, sponsored by Novartis. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-11-08.

Sponsored by Novartis · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study will assess the effectiveness and safety of different combination antihypertensive treatments in patients with severe hypertension

02

Conditions studied

  • Hypertension

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Keywords

  • hypertension
  • high blood pressure
  • valsartan
  • 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 130 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 and older
Sexes eligible
All

Inclusion criteria

  • Patients with severe hypertension

Exclusion criteria

Exclusion Criteria:

  • History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
  • Liver, kidney, or pancreas disease
  • Insulin dependent diabetes
  • Allergy to certain medications used to treat high blood pressure

Other protocol-defined inclusion/exclusion criteria may apply.

05

Study design

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

Interventions

  • Drugvalsartan/amlodipine
06

What researchers measure

Primary outcomes

  1. Adverse events and serious adverse events at each study visit for 6 weeks

Secondary outcomes

  1. Sitting and standing blood pressure measurements after 6 weeks

  2. Laboratory test data after 6 weeks

  3. Vital signs at each study visit for 6 weeks

07

Study locations

1 site
  • Novartis Pharmaceuticals
    East Hanover, New Jersey 07936, United States
08

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 ↗
09

Registry details

Key details

Study ID
NCT00171535
Lead sponsor
Novartis
Responsible party
Sponsor
First posted
Sep 15, 2005
Start date
Oct 2004
Primary completion
Apr 2005
Completion
Apr 2005
Last update
Nov 8, 2011

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 Jun 2006. You cannot join it, but the record below documents what was studied.

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