Status:
COMPLETED
Aliskiren/Amlodipine/Hydrochlorothiazide (HCTZ) Versus Aliskiren/Amlodipine in US Minority Patients With Stage II Systolic Hypertension
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to compare the combination of aliskiren, amlodipine and Hydrochlorothiazide (HCTZ) versus the combination of aliskiren and amlodipine as therapy in minority Stage 2 hyperte...
Eligibility Criteria
Inclusion
- Patients who are newly diagnosed or have a history of hypertension, who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
- Men or women 18 years and older of minority background; self-identified.
- Patients with stage 2 hypertension defined as MSSBP ≥160 mmHg and \<200 mmHg at Visit 5 (randomization).
Exclusion
- Patients with MSDBP ≥110 mmHg and/or MSSBP ≥200 mmHg as measured by office cuff at any visit.
- Patients on 4 or more antihypertensive medications.
- Patients with uncontrolled hypertension (MSSBP \>180 mmHg) taking more than 1 antihypertensive medication at Visit 1.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
412 Patients enrolled
Trial Details
Trial ID
NCT00942994
Start Date
June 1 2009
Last Update
June 8 2011
Active Locations (5)
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1
K and S Research Services
Little Rock, Arkansas, United States, 72201
2
Well Pharma Medical Research
South Miami, Florida, United States, 33143
3
Hyde Park Health Associates
Mattapan, Massachusetts, United States, 02126
4
Manassas Clinical Research Center
Manassas, Virginia, United States, 20110