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| Sponsor: | William Beaumont Hospitals |
|---|---|
| Collaborator: |
Novartis Pharmaceuticals |
| Information provided by: | William Beaumont Hospitals |
| ClinicalTrials.gov Identifier: | NCT00994253 |
Purpose
The purpose of this study is to assess the effect of Tekturna (aliskiren), in combination with an ACE and calcium channel blocker in hypertensive patients diagnosed with Type II diabetes.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension Diabetes Type 2 |
Drug: Prescribe Aliskiren Drug: HCTZ |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
| Official Title: | A Prospective, Randomized, Open-label Clinical Trial to Evaluate the Effect of Tektura (Aliskiren), Angiotensin Inhibitors, Diuretics, and Calcium Channel Blockers on Coronary Flow Reserve in Patients With Type II Diabetes and Hypertension |
| Estimated Enrollment: | 50 |
| Study Start Date: | October 2009 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Aliskiren: Experimental
Patients will be assigned to the treatment arm containing aliskiren. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + aliskiren 150-300mg |
Drug: Prescribe Aliskiren
Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day. All subjects will be prescribed lisinopril40mg and amlodipine 5mg po daily.
|
|
HCTZ: Active Comparator
Patients will be assigned to the treatment arm containing HCTZ. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + HCTZ 12.5-25mg |
Drug: HCTZ
HCTZ will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily
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Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the study drugs including, but not limited to, any of the following:
Contacts and Locations| Contact: Scott Billecke, PhD | Scott.Billecke@beaumont.edu |
| United States, Michigan | |
| William Beaumont Hospital | Recruiting |
| Royal Oak, Michigan, United States, 48073 | |
| Contact: Deborah Collins-Bohler 248-898-2697 Deborah.Collins-Bohler@beaumont.edu | |
| Principal Investigator: Pamela Marcovitz, MD | |
More Information
| Responsible Party: | William Beaumont Hospital ( Pamela Marcovitz, MD ) |
| Study ID Numbers: | 2009-083 |
| Study First Received: | October 12, 2009 |
| Last Updated: | October 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00994253 History of Changes |
| Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
|
Metabolic Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Diuretics Diabetes Mellitus Vascular Diseases Endocrine System Diseases Calcium Channel Blockers Cardiovascular Agents |
Pharmacologic Actions Membrane Transport Modulators Natriuretic Agents Therapeutic Uses Diabetes Mellitus, Type 2 Cardiovascular Diseases Glucose Metabolism Disorders Hypertension |