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

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Valsartan, Valsartan HCT

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension (HTN), High Sensitivity C-Reactive Protein

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All Sexes

Inclusion Criteria: 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 Criteria: 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.

Sites / Locations

Outcomes

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

Full Information

NCT ID

NCT00154271

First Posted

September 8, 2005

Last Updated

November 7, 2011

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00154271

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2006

Overall Recruitment Status

Completed

Study Start Date

January 2004 (undefined)

Primary Completion Date

June 2005 (Actual)

Study Completion Date

June 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

Keywords

Hypertension (HTN), High Sensitivity C-Reactive Protein

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1677 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Valsartan, Valsartan HCT

Primary Outcome Measure Information:

Title

Change from baseline to Week 6 in mean sitting blood pressure (SD)

Title

Change from baseline to Week 12 in median plasma hsCRP

Title

Change from baseline to Week 6 in median plasma hsCRP

Secondary Outcome Measure Information:

Title

Proportion of responders with change in systolic BP

Title

Time to first SBP reduction

Title

Proportion of subjects achieving SBP control

Title

Change in mean sitting DBP

Title

Change in hsCRP for subjects with baseline hsCRP greater or equal to 3.0 mg/L

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

18498915

Citation

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.

Results Reference

derived

Hypertension

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial