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...
Date First Received: September 8, 2005
Last Updated: February 6, 2009
Verified by: Pfizer, February 2009
Clinical Trial Phase: Phase 4 | Start Date: March 2003
Overall Status: Completed
Estimated Enrollment: 739
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Amlodipine
Outcome Measures for this Clinical Trial
Primary 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 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.
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 30 Years
Maximum Age for this Clinical Trial: 75 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Pfizer
Overall Clinical Trial Officials and Contacts
Pfizer CT.gov Call Center Study Director Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00159692
Study ID Number: A0531063
ClinicalTrials.gov Identifier: NCT00159692
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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