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Completed

NCT Number: NCT00446563

Efficacy and Safety of Valsartan in Combination With Amlodipine Compared to Losartan Plus Hydrochlorothiazide in Patients With Hypertension and Left Ventricular Hypertrophy

This study will evaluate the safety and efficacy of amlodipine plus valsartan in patients with hypertension and left ventricular hypertrophy

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Key information

Conditions

Hypertension; Hypertrophy, Left Ventricular Cardiomegaly Cardiovascular Diseases Heart Diseases Hypertension Hypertrophy Hypertrophy, Left Ventricular Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

25 centers in Germany

Ludwigshafen, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Caucasian; male or female outpatients and age between 18-80 years of age, inclusive.
  • Patients with a history of essential hypertension and who are actually treated either with an antihypertensive monotherapy and with a diastolic blood pressure >=90 and <= 105mmHg or with a combination therapy (limited to two active compounds) and with a diastolic blood pressure of >=90 and <= 100mmHg.
  • Patients with Left Ventricular Hypertrophy

Exclusion criteria

  • Severe hypertension
  • Symptomatic heart failure
  • History of stroke, heart attack, coronary bypass surgery etc.
  • Insulin-dependent diabetes mellitus or poorly controlled diabetes mellitus.

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

valsartan

Drug

160 mg film coated tablets taken orally once daily in the morning.

Amlodipine

Drug

5 mg or 10 mg tablets taken orally once daily in the morning.

Hydrochlorothiazide

Drug

12.5 mg or 25 mg tablets taken orally once daily in the morning.

Losartan

Drug

100 mg tablets taken orally once daily in the morning.

Primary outcomes

  1. Change From Baseline in Left Ventricular Mass Index (LVMI) Measured Via Magnetic Resonance Imaging (MRI)

    Time frame: Baseline to week 52

Secondary outcomes

  1. Change From Baseline to the End of Study in Left Ventricular Mass Index (LVMI) Normalized to Body Surface Area Assessed by MRI

    Time frame: Baseline to week 52

  2. Change From Baseline to the End of Study in Interventricular Septum Thickness (IVS) Assessed by MRI

    Time frame: Baseline to week 52

  3. Change From Baseline to the End of Study in Posterior Wall Thickness Assessed by MRI

    Time frame: Baseline to week 52

  4. Change From Baseline to the End of Study in Left Ventricular Ejection Fraction (LVEF) Assessed by MRI

    Time frame: Baseline to week 52

    Ejection fraction is a measurement of the percentage of blood that is pumped out of a filled ventricle with each heartbeat.

  5. Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Assessed by MRI

    Time frame: Baseline to week 52

  6. Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Normalized to Body Surface Area Assessed by MRI

    Time frame: Baseline to week 52

  7. Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Assessed by MRI

    Time frame: Baseline to week 52

  8. Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Normalized to Body Surface Area Assessed by MRI

    Time frame: Baseline to week 52

  9. Change From Baseline to the End of Study in Left Atrial (LA) Area Assessed by MRI

    Time frame: Baseline to week 52

  10. Change From Baseline to the End of Study in the Ascending Aortic Diameter Assessed by MRI

    Time frame: Baseline to week 52

  11. Change From Baseline to End of Study in Levels of N-terminal Pro-B Type Natriuretic Peptide (NT-proBNP)

    Time frame: Baseline to week 52

  12. Change From Baseline to End of Study in Levels of High-sensitivity C-reactive Protein (Hs-CRP)

    Time frame: Baseline to week 52

  13. Percentage of Participants Achieving Target Blood Pressure at Week 52

    Time frame: Week 52

    Target blood pressure defined as having a mean sitting systolic blood pressure (MSSBP) < 140 mm Hg and a mean sitting diastolic blood pressure (MSDBP) < 90 mm Hg.

  14. Percentage of Participants Who Experienced Adverse Events (AEs)

    Time frame: Baseline to week 52

    An adverse event was the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after obtaining informed consent even if the event was not considered to be related to study drug. Medical conditions/diseases present before obtaining informed consent were only considered adverse events if they worsened after study start. Abnormal laboratory values or test results constituted adverse events only if they induced clinical signs or symptoms, required study drug discontinuation or required therapy.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

An Open-label, Randomized, Parallel Group Study Comparing the Efficacy and Safety of Amlodipine in Combination With Valsartan Compared to Losartan in Combination With Hydrochlorothiazide Given for 52 Weeks on the Regression of Left Ventricular Hypertrophy in Patients With Mild to Moderate Hypertension

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Mar 13, 2007
Registry last updated
May 11, 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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