HypertensionPhase 3AMAZINGNCT00867490

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

A Phase 3 study testing Candesartan+HCTZ - Phase 1, Aliskiren+HCTZ - Phase 2 and Aliskiren+HCTZ+amlodipine - Phase 3 in people with Hypertension, run by Novartis at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension
What is being tested?: Candesartan+HCTZ - Phase 1, Aliskiren+HCTZ - Phase 2 and Aliskiren+HCTZ+amlodipine - Phase 3
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 186 participants
Where: 1 siteGermany
Study dates: Mar 2009to Aug 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with mean sitting diastolic blood pressure ≥ 100 mmHg and < 110 mmHg
msSBP ≥ 140 mm Hg and/or msDBP ≥ 90 mm Hg at Visit 5 of the core study

Who cannot join

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
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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Investigative Site
Chemnitz

Other trials in Germany

About this study

Official 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

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.

Read the detailed description

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

Conditions: Hypertension
Being tested: Candesartan+HCTZ - Phase 1, Aliskiren+HCTZ - Phase 2, Aliskiren+HCTZ+amlodipine - Phase 3
Keywords: Hypertension, aliskiren, cardiovascular diseases
Medical subject headings: Hypertension, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Candesartan+HCTZ - Phase 1Drug
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 2Drug
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 3Drug
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.

Study groups in NCT00867490
Study group	Role	What they receive
Candesartan+HCTZ, aliskiren+HCTZ, aliskiren+HCTZ+amlodipine	Experimental	Not described Receives: Drug: Candesartan+HCTZ - Phase 1; Drug: Aliskiren+HCTZ - Phase 2; Drug: Aliskiren+HCTZ+amlodipine - Phase 3

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study
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.
Measured: Baseline Phase 2 to end of Phase 2
Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study
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.
Measured: Baseline Phase 3 to end of Phase 3

Secondary outcomes (10)

Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study
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.
Measured: Baseline Phase 2 to end of Phase 2
Change in Sitting Pulse Pressure During the Core Phase of the Study
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.
Measured: Baseline Phase 2 to end of Phase 2
Change in Sitting Pulse Rate During the Core Phase of the Study
Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.
Measured: Baseline Phase 2 to end of Phase 2
Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study
Normalized blood pressure was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg.
Measured: Baseline Phase 2 to end of Phase 2
Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study
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.
Measured: Baseline Phase 2 to end of Phase 2
Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study
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.
Measured: Baseline Phase 3 to end of Phase 3
Change in Sitting Pulse Pressure During the Extension Phase of the Study
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.
Measured: Baseline Phase 3 to end of Phase 3
Change in Sitting Pulse Rate During the Extension Phase of the Study
Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.
Measured: Baseline Phase 3 to end of Phase 3
Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study
Normalized was defined as a msSBP < 140 mm Hg and/or a msDBP < 90 mm Hg.
Measured: Baseline Phase 3 to end of Phase 3
Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study
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.
Measured: Baseline Phase 3 to end of Phase 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Aug 2009

First posted23 Mar 2009 (estimated)
Study startMar 2009
Primary completionAug 2009
Study completionAug 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 186 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00867490
Sponsor's protocol ID: CSPH100ADE01
Acronym: AMAZING
Status last verified: May 2011
First submitted: 20 Mar 2009
Last updated: 6 May 2011
Results posted: Yes, on ClinicalTrials.gov

Publications

Schweizer J, Ulmer HJ, Benduhn H, Klebs S. Efficacy and tolerability of aliskiren 300 mg/hydrochlorothiazide 25 mg (+/- amlodipine 5 mg) in hypertensive patients not controlled by candesartan 32 mg plus HCT 25 mg. Curr Med Res Opin. 2011 Jan;27(1):131-40. doi: 10.1185/03007995.2010.537318. Epub 2010 Nov 30.
PubMed 21117946

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT00867490
Acronym / sponsor ID: AMAZING / CSPH100ADE01
Conditions: Hypertension
Keywords: Hypertension, aliskiren, cardiovascular diseases
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 186 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 23 Mar 2009 (estimated)
Results: Posted 1 Feb 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Candesartan+HCTZ, aliskiren+HCTZ, aliskiren+HCTZ+amlodipine	Experimental	Drug: Candesartan+HCTZ - Phase 1, Drug: Aliskiren+HCTZ - Phase 2, Drug: Aliskiren+HCTZ+amlodipine - Phase 3

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients with mean sitting diastolic blood pressure ≥ 100 mmHg and < 110 mmHg
msSBP ≥ 140 mm Hg and/or msDBP ≥ 90 mm Hg at Visit 5 of the core study

Key exclusion criteria (8 listed)

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
Premature discontinuation in the core study or failure to comply with the core study protocol

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Candesartan+HCTZ - Phase 14 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.	Drug	Candesartan+HCTZ, aliskiren+HCTZ, aliskiren+HCTZ+amlodipine
Aliskiren+HCTZ - Phase 2Patients 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.	Drug	Candesartan+HCTZ, aliskiren+HCTZ, aliskiren+HCTZ+amlodipine
Aliskiren+HCTZ+amlodipine - Phase 3The 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.	Drug	Candesartan+HCTZ, aliskiren+HCTZ, aliskiren+HCTZ+amlodipine

Primary outcome

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.
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.

10 secondary outcomes

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
Change in Sitting Pulse Pressure During the Core Phase of the Study
Time frame: Baseline Phase 2 to end of Phase 2
Change in Sitting Pulse Rate During the Core Phase of the Study
Time frame: Baseline Phase 2 to end of Phase 2
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
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
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
Change in Sitting Pulse Pressure During the Extension Phase of the Study
Time frame: Baseline Phase 3 to end of Phase 3
Change in Sitting Pulse Rate During the Extension Phase of the Study
Time frame: Baseline Phase 3 to end of Phase 3
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
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

Results and safety

Results posted to the registry on 1 Feb 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Candesartan+HCTZ, Aliskiren+HCTZ, Aliskiren+HCTZ+Amlodipine	186	176

Primary outcome: 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. Mean (95% Confidence Interval). Unit: mmHg

Measure	Phase 2 - Aliskiren+HCTZ n = 123
Value	-3.12 (-4.29 to -1.95)

Population analysed: Intent-to-treat population (ITT): All patients who took at least one dose of aliskiren plus HCTZ who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.

Primary outcome: 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. Mean (95% Confidence Interval). Unit: mmHg

Measure	Phase III - Aliskiren+HCTZ+Amlodipine n = 61
Value	-5.87 (-7.48 to -4.26)

Population analysed: Safety population: All patients who took at least one dose of aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg.

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1 - Candesartan+HCTZ	1 of 186 (0.5%)	0 of 186 (0%)	Not reported
Phase 2 - Aliskiren+HCTZ	2 of 123 (1.6%)	0 of 123 (0%)	Not reported
Phase 3 - Aliskiren+HCTZ+Amlodipine	0 of 61 (0%)	0 of 61 (0%)	Not reported

Limitations and caveats (from the sponsor): The Phases of this study were entered in separate tables for outcomes and the Phases for SAEs and the AEs were entered all in one table.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21117946Schweizer J, Ulmer HJ, Benduhn H, Klebs S. Efficacy and tolerability of aliskiren 300 mg/hydrochlorothiazide 25 mg (+/- amlodipine 5 mg) in hypertensive patients not controlled by candesartan 32 mg plus HCT 25 mg. Curr Med Res Opin. 2011 Jan;27(1):131-40. doi: 10.1185/03007995.2010.537318. Epub 2010 Nov 30.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis study director

Novartis

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Candesartan+HCTZ - Phase 1, Aliskiren+HCTZ - Phase 2 and Aliskiren+HCTZ+amlodipine - Phase 3 in people with Hypertension, run by Novartis at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00867490, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2011.