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CompletedNCT00351130Updated Feb 24, 2017

Effectiveness of a Valsartan Based vs an Amlodipine Based Treatment Strategy in naïve Patients With Stage 1 or Stage 2 Hypertension or in Patients Uncontrolled on Current Monotherapy

A Phase 4 interventional study of valsartan and amlodipine in Hypertension, sponsored by Novartis. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-02-24.

Sponsored by Novartis · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
79
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Essential hypertension is a widespread disease which affects one out of every three adults in the industrialized world. It contributes to cardiovascular disease development, a major and well established risk factor. A patient non compliant to drug therapy is recognized as one of the primary reasons for inadequate blood pressure control.

02

Conditions studied

  • Hypertension

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Keywords

  • Hypertension,
  • stage 1 hypertension,
  • stage 2 hypertension,
  • 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 79 is below 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 75 Years
Sexes eligible
All

Inclusion criteria

  • MSSBP> 140 mm Hg, and/or MSDBP> 90 mm Hg and currently treated with either valsartan 320 mg/ HCTZ 25 mg or amlodipine 10 mg/HCTZ 25 mg at end of core study

Exclusion criteria

Exclusion criteria

  • Premature discontinuation in the core study or failure to comply with the core study protocol
  • Any patient that the investigator decides should not participate in the extension

Other protocol-defined inclusion/exclusion criteria may apply

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
79 participants (actual)

Interventions

  • Drugvalsartan
  • Drugamlodipine
06

What researchers measure

Primary outcomes

  1. Percentage of patients who reach BP goal, systolic <140 mmHg and diastolic <90 mmHg, after 22 weeks

Secondary outcomes

  1. Percentage of patients who reach BP goal, systolic <140 mmHg and diastolic <90 mmHg, after 14 and 22 weeks

  2. Adverse events after 22 weeks

07

Study locations

2 sites
  • Investigative Centers, Germany
  • Novartis Pharmaceuticals
    Basel, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00351130
Lead sponsor
Novartis
Responsible party
Sponsor
First posted
Jul 12, 2006
Start date
Jun 2006
Primary completion
Mar 2007
Completion
Mar 2007
Last update
Feb 24, 2017

Study contacts

Novartis Pharmaceuticals
study director · Novatis 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.

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