Status:
COMPLETED
Effects of Blood Pressure Reduction on High Sensitivity C-Reactive Protein (hsCRP)
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The study compares the efficacy of an aggressive versus a moderate initial antihypertensive regimen to reduce blood pressure in patients with Stage 2 hypertension. Additionally, the study examines the...
Eligibility Criteria
Inclusion
- Stage 2 hypertension as defined by the mean of three (3) repeated seated BP measurements of: SBP of 160 to 185 mmHg, inclusive and/or DBP of 100 to 109 mmHg, inclusive.
- Patients must have documentation of serum creatinine equal or \<2.0 mg/dL, serum potassium equal or \>3.5 and equal or \<5.5 mmol/L, and serum AST or ALT \<2xULN obtained within 3 months prior to Visit 1.
- Patients must have documentation of HbA1C equal or \<11.0 % obtained within 1 month prior to Visit 1.
Exclusion
- History of secondary hypertension.
- Pharmacologic antihypertensive therapy with ACE inhibitors, angiotensin receptor blockers, or aldosterone blockers within 3 months prior to Visit 1, or with thiazide diuretics within 1 month prior to Visit 1. The use of other classes of agents which lower BP but are being used for other therapy or for HTN, are allowed as long as these agents are started at least 3 months prior to randomization, are not initiated after enrollment and doses remain unchanged during the study.
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
1677 Patients enrolled
Trial Details
Trial ID
NCT00154271
Start Date
January 1 2004
End Date
June 1 2005
Last Update
November 8 2011
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