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Amlodipine Diabetic Hypertension Efficacy Response Trial (ADHERE)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00159692
First received: September 8, 2005
Last updated: February 6, 2009
Last verified: February 2009
History of Changes
  Purpose

To evaluate the percentage of subjects that reach the diabetic hypertensive blood pressure goal of <130/80 with amlodipine versus placebo in subjects initially treated with quinapril or losartan.


Condition Intervention Phase
Hypertension
 Drug: Amlodipine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Double-Blind, Double-Dummy Study Evaluating The Safety and Efficacy Of The Addition Of Amlodipine To Quinapril Or Losartan In The Treatment Of Diabetic Hypertensive Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The percentage of subjects that reach the JNC diabetic hypertensive BP goal of <130/80 will be assessed at Week 0 (Visit 2-Randomization), Week 5 (Visit 3), Week 9 (Visit 4), Week 15 (Visit 5) and Week 20 (Visit 6 - Final Evaluation).

Secondary Outcome Measures:
  • Percentage of subjects at SBP goal of <130 mmHg and DBP goal of <80mmHg; change from baseline blood pressures (SBP and DBP); percentage of subjects with SBP >160mmHg and/or DBP >100mmHg at Visits 2, 3, 4, 5, 6.

Enrollment: 739
Study Start Date: March 2003
Study Completion Date: August 2005
  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented evidence of Type 2 diabetes as defined by the ADA guidelines and documented evidence of Hypertension (various SBP/DBP ranges).

Exclusion Criteria:

  • A previous history or intolerance or hypersensitivity to calcium channel blockers, ARBs or ACE inhibitors.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00159692

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00159692     History of Changes
Other Study ID Numbers: A0531063
Study First Received: September 8, 2005
Last Updated: February 6, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Calcium Channel Blockers
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 21, 2013