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CompletedNCT00171366Updated Apr 6, 2016

A Study Comparing the Response of Patients With Hypertension to Amlodipine or Amlodipine Plus Benazepril.

A Phase 3 interventional study of amlodipine/benazepril 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 2016-04-06.

Sponsored by Novartis · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,422
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Comparison of the safety and efficacy of the combination of amlodipine/Benazepril to amlodipine monotherapy in patients with non-essential hypertension, not controlled on amlodipine alone.

02

Conditions studied

  • Hypertension

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Keywords

  • amlodipine
  • benazepril
  • hypertension
  • diastolic
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 1,422 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

  • Outpatients 18 years of age or older.
  • Male or female patients are eligible. Female patients must be either post-menopausal for one year or surgically sterile, or using effective, contraceptive methods such as barrier method with spermicide, or an intrauterine device.
  • Patients with essential hypertension as measured by a validated device

Exclusion criteria

Exclusion Criteria:

  • Severe hypertension (DBP > 115 mmHg diastolic and/or SBP > 180 mmHg systolic).

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
1,422 participants (actual)

Interventions

  • Drugamlodipine/benazepril
06

What researchers measure

Primary outcomes

  1. Change from baseline in mean sitting diastolic blood pressure at week 6

Secondary outcomes

  1. Change from baseline in mean sitting systolic blood pressure at week 6

  2. Change from week 2 in mean sitting diastolic and systolic blood pressure at week 6

  3. Diastolic response rate at week 6. Patients were considered responders if they had a mean sitting diastolic blood pressure of < 90 mmHg or a >= 10 mm Hg decrease compared to baseline.

  4. Change from baseline in 24 hour diastolic and systolic blood pressure at week 6

  5. Change from baseline in 24 hour diastolic and systolic blood pressure at peak which is defined as the lowest hourly blood pressure mean and the average of the hourly means from 4 to 6 hours post dose at week 6

07

Study locations

1 site
  • Novartis Pharmaceuticals
    E. 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 Apr 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00171366
Lead sponsor
Novartis
Collaborators
Pfizer
Responsible party
Sponsor
First posted
Sep 15, 2005
Start date
Jul 2004
Primary completion
Jul 2005
Completion
Jul 2005
Last update
Apr 6, 2016

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 Apr 2016. You cannot join it, but the record below documents what was studied.

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