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

NCT00154271 | Completed Phase 4

• 1 other identifier: CVAH631DUS02
• Study Type: interventional
• Target: 1,677
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Hypertension

Keywords

Hypertension (HTN); High Sensitivity C-Reactive Protein

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

Interventions

Valsartan, Valsartan HCT DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead

Related Publications (1)

• Everett BM, Glynn RJ, Danielson E, Ridker PM; Val-MARC Investigators. Combination therapy versus monotherapy as initial treatment for stage 2 hypertension: a prespecified subgroup analysis of a community-based, randomized, open-label trial. Clin Ther. 2008 Apr;30(4):661-72. doi: 10.1016/j.clinthera.2008.04.013.

  PMID: 18498915 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Valsartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: January 1, 2004
• Primary Completion: June 1, 2005
• Study Completion: June 1, 2005
• Last Updated: November 8, 2011

Record last verified: 2006-08