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Completed

NCT Number: NCT00154271

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Valsartan, Valsartan HCT

Drug

Primary outcomes

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

  2. Change from baseline to Week 12 in median plasma hsCRP

  3. Change from baseline to Week 6 in median plasma hsCRP

Secondary outcomes

  1. Proportion of responders with change in systolic BP

  2. Time to first SBP reduction

  3. Proportion of subjects achieving SBP control

  4. Change in mean sitting DBP

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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 12, 2005
Registry last updated
Nov 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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