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Completed

NCT Number: NCT00867490

Safety and Efficacy of Aliskiren + Hydrochlorothiazide (± Amlodipine 5 mg) in Patients With Moderate Hypertension

This study will assess the safety and efficacy of aliskiren plus hydrochlorothiazide (HCTZ) in patients who do not achieve controlled blood pressure levels after treatment with another specified antihypertensive medication. There was an optional study extension for the first eligible 60 patients who wanted to participate that contains the triple therapy with amlodipine 5 mg and aliskiren 300 mg plus HCTZ 25 mg.

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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

Investigative Site

Chemnitz, Germany

About this study

Title of study extension: An open-label, multicenter extension to evaluate the efficacy and safety of a 4 week therapy with amlodipine 5 mg and aliskiren 300 mg plus HCTZ 25 mg in hypertensive patients not adequately responding to a 4 week therapy each with the combinations of candesartan 32 mg plus hydrochlorothiazide 25 mg followed by aliskiren 300mg plus hydrochlorothiazide 25 mg

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

for Core Study:

  • Patients with mean sitting diastolic blood pressure ≥ 100 mmHg and < 110 mmHg

Inclusion criteria

for the Extension:

  • msSBP ≥ 140 mm Hg and/or msDBP ≥ 90 mm Hg at Visit 5 of the core study

Exclusion criteria

for Core Study:

  • Patients with mean diastolic blood pressure ≥ 110 mmHg or mean systolic blood pressure ≥ 180 mmHg
  • Patients with prior stroke, hypertensive encephalopathy or heart attack
  • Patients with type 1 diabetes mellitus
  • Patients with type 2 diabetes mellitus with poor glucose control

Exclusion criteria

for the Extension:

  • Premature discontinuation in the core study or failure to comply with the core study protocol
  • History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures, known or suspected contraindications to diuretics as described in the SmPC (particularly amlodipine 5 mg), e.g. severe hypotension, shock - including cardiogenic shock, obstructions impairing the flow out of the left ventricle (e.g. significant aortic stenosis)
  • Any patient that the investigator decides should not participate in the extension study for medical reasons

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

Treatment and study plan

Candesartan+HCTZ - Phase 1

Drug

4 weeks treatment with candesartan 32 mg (two 16 mg tablets) plus hydrochlorothiazide 25 mg (two 12.5 mg tablets) taken orally with water in the morning between 7 and 10 am.

Aliskiren+HCTZ - Phase 2

Drug

Patients with uncontrolled mean sitting diastolic blood pressure (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.

Aliskiren+HCTZ+amlodipine - Phase 3

Drug

The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg in a single tablet plus an amlodipine 5 mg tablet taken orally with water in the morning between 7 and 10 am.

Primary outcomes

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

    Time frame: Baseline Phase 2 to end of Phase 2

    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 to end of Phase 3

    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 to end of Phase 2

    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 to end of Phase 2

    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 to end of Phase 2

    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 to end of Phase 2

    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 Phase 2 to end of Phase 2

    Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 2 compared to Baseline in Phase 2 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 to end of Phase 3

    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 to end of Phase 3

    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 to end of Phase 3

    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 Core Phase of the Study

    Time frame: Baseline Phase 3 to end of Phase 3

    Normalized was defined as a msSBP < 140 mm Hg and/or a msDBP < 90 mm Hg.

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

    Time frame: Baseline Phase 3 to end of Phase 3

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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of a 4 Week Therapy With Aliskiren 300 mg Plus Hydrochlorothiazide 25 mg in Hypertensive Patients Not Adequately Responding to a 4 Week Therapy With Candesartan 32 mg Plus Hydrochlorothiazide 25 mg

Acronym: AMAZING

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 23, 2009
Registry last updated
May 6, 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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