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Completed

NCT Number: NCT00523744

Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension

This study will evaluate the efficacy and safety of valsartan and amlodipine in fixed dose combination in adults with moderate, inadequately controlled hypertension. There was an optional study extension for eligible patients who wanted to participate that contains the triple therapy (ie, hydrochlorothiazide+ amlodipine/valsartan).

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, , Germany, Schwerin, Germany

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About this study

Title of study extension: An open-label, multicenter extension to evaluate the efficacy and tolerability of a 4 week therapy with hydrochlorothiazide 12.5 mg plus amlodipine 10 mg/valsartan 160 mg in hypertensive patients not adequately responding to a 4 week therapy each with the combinations of olmesartan 20 mg plus amlodipine 10 mg followed by amlodipine 10 mg/valsartan 160 mg

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

for Core study:

  • Male or female patients (>=18 years)
  • Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods
  • Patients with essential hypertension (diastolic blood pressure >=100 mmHg and <110 mmHg)

Inclusion criteria

for Extension:

  • Patients had to have a msSBP >= 140 mmHg and/or msDBP >= 90 mmHg at week 8 ie, end of core study.

Exclusion criteria

for Core study:

  • Severe hypertension (diastolic blood pressure >=110 mmHg or systolic blood pressure >= 180 mmHg)
  • Pregnant or nursing women
  • Treated hypertensive patients with controlled hypertension under current therapy
  • A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV

Exclusion criteria

for Extension:

  • prematurely discontinued the core study
  • failed to comply with the core study protocol

Other protocol-defined inclusion/exclusion criteria applied to the study.

Treatment and study plan

Amlodipine

Drug

Amlodipine supplied as 5 mg tablets, taken orally once a day during Treatment Phase 1 only.

olmesartan medoxomil

Drug

Olmesartan medoxomil supplied as 10 mg tablets taken once a day during Treatment Phase 1 only.

Amlodipine+valsartan

Drug

Fixed-dose combination of amlodipine 10 mg plus valsartan 160 mg tablet taken orally once a day during Treatment Phase 2 and Extension Phase.

Other names: Exforge

Hydrochlorothiazide

Drug

Hydrochlorothiazide (HCTZ) 12.5 mg tablets taken once a day during the Extension Phase.

Other names: Sandoz

Primary outcomes

  1. Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study

    Time frame: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)

    The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.

  2. Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study

    Time frame: Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)

    The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.

Secondary outcomes

  1. Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study

    Time frame: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)

    The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.

  2. Change in Sitting Pulse Pressure During the Core Phase of the Study

    Time frame: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)

    Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.

  3. Change in Sitting Pulse Rate During the Core Phase of the Study

    Time frame: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)

    Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.

  4. Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study

    Time frame: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)

    Normalized Blood Pressure was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg.

  5. Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study

    Time frame: Baseline of Phase 2 (Week 4) to end of Phase 2 (Week 8)

    Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 2 (Week 8) compared to Baseline in Phase 2 (week 4) or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 2 compared to Baseline in Phase 2.

  6. Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study

    Time frame: Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)

    The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.

  7. Change in Sitting Pulse Pressure During the Extension Phase of the Study

    Time frame: Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)

    Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.

  8. Change in Sitting Pulse Rate During the Extension Phase of the Study

    Time frame: Baseline Phase 3 (Week 8) to end of Phase 3 (week 12)

    Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.

  9. Percentage of Patients Who Achieved Normalized Blood Pressure During the Extension Phase of the Study

    Time frame: Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)

    Normalized Blood Pressure was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg.

  10. Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Extension Phase of the Study

    Time frame: Baseline of Phase 3 (Week 8) to end of Phase 3 (Week 12)

    Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 3 compared to Baseline in Phase 3 or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 3 compared to Baseline in Phase 3.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

An Open-label, Multicenter Study to Evaluate the Efficacy and Tolerability of a 4 Week Therapy With the Fixed Dose Combination of Amlodipine 10 mg Plus Valsartan 160 mg in Hypertensive Patients Not Adequately Responding to a 4 Week Therapy With the Free Combination of an Angiotensin Receptor Blocker (Olmesartan 20 mg) Plus Amlodipine 10 mg

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Aug 31, 2007
Registry last updated
Aug 4, 2020

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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