NCT00136851

Brief Summary

This trial is designed to study the efficacy of an amlodipine besylate/benazepril treatment regimen versus an amlodipine treatment regimen in the treatment of severe hypertension.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
259

participants targeted

Target at P50-P75 for phase_4 hypertension

Timeline
Completed

Started Dec 2004

Shorter than P25 for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
Last Updated

November 8, 2011

Status Verified

June 1, 2006

Enrollment Period

7 months

First QC Date

August 26, 2005

Last Update Submit

November 7, 2011

Conditions

Hypertension

Keywords

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Percentage of subjects achieving blood pressure goal which is defined as < 140/90 mm Hg, or < 130/80 mm Hg in subjects with diabetes after 4 weeks

Secondary Outcomes (4)

  • Percentage of subjects achieving blood pressure goal, defined as < 140/90 mm Hg, or < 130/80 mm Hg in subjects with diabetes after 6 weeks

  • Change from baseline in the mean sitting systolic blood pressure after 4 and 6 weeks

  • Change from baseline in the mean sitting diastolic blood pressure after 4 and 6 weeks

  • Percentage of subjects with swelling in legs or arms after 4 and 6 weeks

Interventions

amlodipine besylate/benazepril hydrochlorideDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of severe hypertension

You may not qualify if:

  • Diastolic blood pressure (DBP) \< 60 mm Hg
  • Serum potassium \< 3.5 or \> 5.5 mEq/L in the absence of all potassium supplements
  • Refractory hypertension defined as systolic blood pressure (SBP) ≥ 180 mmHg and/or DBP ≥ 110 mmHg and unresponsive to triple-drug regimens

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Location

Related Publications (1)

  • Izzo JL Jr, Purkayastha D, Hall D, Hilkert RJ. Comparative efficacy and safety of amlodipine/benazepril combination therapy and amlodipine monotherapy in severe hypertension. J Hum Hypertens. 2010 Jun;24(6):403-9. doi: 10.1038/jhh.2009.80. Epub 2009 Nov 5.

    PMID: 19890370DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

benazepril

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2005

First Posted

August 29, 2005

Study Start

December 1, 2004

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

November 8, 2011

Record last verified: 2006-06

Locations

US(1)