A Study Comparing the Response of Patients With Hypertension to Amlodipine or Amlodipine Plus Benazepril. - Full Text View

Sponsor:	Novartis
Collaborator:	Pfizer
Information provided by (Responsible Party):	Novartis
ClinicalTrials.gov Identifier:	NCT00171366

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: amlodipine/benazepril	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Multicenter, Group Study to Evaluate the Safety and Efficacy of Amlodipine and Benazepril Administered in Combination Compared to Amlodipine Monotherapy in Hypertensive Patients Not Adequately Controlled With Amlodipine Alone

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Benazepril hydrochloride Benazepril Amlodipine Amlodipine besylate Lotrel

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Change from baseline in mean sitting systolic blood pressure at week 6
Change from week 2 in mean sitting diastolic and systolic blood pressure at week 6
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.
Change from baseline in 24 hour diastolic and systolic blood pressure at week 6
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

Enrollment:	1422
Study Start Date:	July 2004
Study Completion Date:	July 2005
Primary Completion Date:	July 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

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:

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

Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171366

Locations

United States, New Jersey
Novartis Pharmaceuticals
E. Hanover, New Jersey, United States, 07936

Sponsors and Collaborators

Novartis

Pfizer

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00171366 History of Changes
Other Study ID Numbers:	CCIB002H2304
Study First Received:	September 12, 2005
Last Updated:	November 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

amlodipine
benazepril
hypertension
diastolic

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Benazepril
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012