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Effects of Blood Pressure Reduction on High Sensitivity C-Reactive Protein (hsCRP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00154271
First Posted: September 12, 2005
Last Update Posted: November 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis
  Purpose
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 effects of blood pressure reduction on the levels of high sensitivity hsCRP. Although the main goal is to determine the overall effect of blood pressure reduction on hsCRP levels, analysis will also evaluate whether an aggressive antihypertensive regimen is more effective than a moderate one in reducing hsCRP levels.

Condition Intervention Phase
Hypertension Drug: Valsartan, Valsartan HCT Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Blood Pressure Reduction on High Sensitivity C-Reactive Protein (hsCRP)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline to Week 6 in mean sitting blood pressure (SD)
  • Change from baseline to Week 12 in median plasma hsCRP
  • Change from baseline to Week 6 in median plasma hsCRP

Secondary Outcome Measures:
  • Proportion of responders with change in systolic BP
  • Time to first SBP reduction
  • Proportion of subjects achieving SBP control
  • Change in mean sitting DBP
  • Change in hsCRP for subjects with baseline hsCRP greater or equal to 3.0 mg/L

Enrollment: 1677
Study Start Date: January 2004
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Patients must have documentation of HbA1C equal or <11.0 % obtained within 1 month prior to Visit 1.

Exclusion Criteria:

  1. History of secondary hypertension.
  2. 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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00154271


Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00154271     History of Changes
Other Study ID Numbers: CVAH631DUS02
First Submitted: September 8, 2005
First Posted: September 12, 2005
Last Update Posted: November 8, 2011
Last Verified: August 2006

Keywords provided by Novartis:
Hypertension (HTN)
High Sensitivity C-Reactive Protein

Additional relevant MeSH terms:
Hypertension
Hypersensitivity
Vascular Diseases
Cardiovascular Diseases
Immune System Diseases
Valsartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action