HypertensionPhase 4ATLAASTNCT00739596

Blood Pressure Lowering of Aliskiren Hydrochlorothiazide (HCTZ) Versus Amlodipine in Stage 2 Hypertension in African Americans

A Phase 4 study testing Aliskiren Hydrochlorothiazide (HCTZ): 8 weeks and Amlodipine: 8 weeks in people with Hypertension, run by Novartis Pharmaceuticals at 1 site in United States.

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

The purpose of the study is to evaluate the efficacy and safety of a fixed dose combination of aliskiren HCTZ versus amlodipine in African American patients with Stage 2 hypertension. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension
What is being tested?: Aliskiren Hydrochlorothiazide (HCTZ): 8 weeks and Amlodipine: 8 weeks
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 332 participants
Where: 1 siteUnited States
Study dates: Jul 2008to Mar 2009
Phase: Phase 4
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 who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
Men or women 18 years and older of African American background; self identified
Patients with stage 2 hypertension. Patients must have a MSSBP ≥ 160 mmHg and < 200 mmHg at Visit 5 (randomization)

Who cannot join

Office blood pressure measured by cuff (MSSBP ≥ 200 mmHg and/or MSDBP ≥ 110 mmHg) at any visit.
Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives whichever is longer.
History of hypersensitivity to any of the study drugs or to drugs belonging to the same therapeutic class (CCBs or thiazide diuretics) as the study drugs.
Long QT syndrome or QTc > 450 msec for males and > 470 msec for females at screening.
History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL)

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Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method.
Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent. Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation.
Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL [and estradiol < 20 pg/mL] or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
History or evidence of a secondary form of hypertension.
Known Keith-Wagener Grade III or IV hypertensive retinopathy.
History of cerebrovascular accident, transient ischemic cerebral attack (TIA), heart failure (NYHA Class II-IV), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) in the last 12 months.
Current angina pectoris requiring pharmacological therapy.
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

1 site in 1 country.

United States1 site

Sites in USA
East Hanover, New Jersey

Other trials in United States

About this study

Official title: An 8 Week Prospective, Multicenter, Randomized, Double-Blind, Active Control, Parallel Group Study to Evaluate the Efficacy and Safety of Aliskiren HCTZ Versus Amlodipine in African American Patients With Stage 2 Hypertension

The purpose of the study is to evaluate the efficacy and safety of a fixed dose combination of aliskiren HCTZ versus amlodipine in African American patients with Stage 2 hypertension.

Conditions: Hypertension
Being tested: Aliskiren Hydrochlorothiazide (HCTZ): 8 weeks, Amlodipine: 8 weeks
Keywords: Hypertension, African American, aliskiren, hydrochlorothiazide, systolic blood pressure, diastolic blood pressure, amlodipine, stage 2
Medical subject headings: Hypertension

What participants receive

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

Aliskiren Hydrochlorothiazide (HCTZ): 8 weeksDrug
Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
Amlodipine: 8 weeksDrug
Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks

Study groups in NCT00739596
Study group	Role	What they receive
Aliskiren Hydrochlorothiazide (HCTZ)	Experimental	Not described Receives: Drug: Aliskiren Hydrochlorothiazide (HCTZ): 8 weeks
Amlodipine	Active comparator	Not described Receives: Drug: Amlodipine: 8 weeks

What is being measured

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

Change in Mean Sitting Systolic Blood Pressure (MSSBP) After 8 Weeks of Treatment
To assess the change from baseline in MSSBP after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension.
Measured: Baseline and 8 weeks

Secondary outcomes (4)

Change in Mean Sitting Diastolic Blood Pressure (MSDBP) After 8 Weeks of Treatment
To assess the change from baseline in mean sitting diastolic blood pressure (MSDBP) after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension.
Measured: Baseline and 8 weeks
Change in Mean Sitting Pulse Pressure (MSPP) After 8 Weeks of Treatment
To compare the change from baseline in mean sitting pulse pressure (MSPP) after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension.
Measured: Baseline and 8 weeks
Percentage of Responders After 8 Weeks of Treatment.
To compare the percentage of responders after 8 weeks of treatment with an aliskiren HCTZ based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension: [ Responders were defined as patients with MSSBP < 140 mm Hg or a decrease from baseline ≥ 20 mm Hg at 1st response. A response was counted when a patient first achieved MSSBP < 140 mm Hg or a decrease from baseline ≥ 20 mm Hg.]
Measured: 8 weeks
Percentage of Participants Achieving BP Control After 8 Weeks of Treatment
To compare the percentage of patients achieving BP control (<140/90 mm Hg) after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension.
Measured: 8 weeks

Timeline

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

Jul 2008Mar 2009

First posted22 Aug 2008 (estimated)
Study startJul 2008
Primary completionMar 2009
Study completionMar 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.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 332 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00739596
Sponsor's protocol ID: CSPP100AUS03
Acronym: ATLAAST
Status last verified: Feb 2011
First submitted: 21 Aug 2008
Last updated: 27 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Ferdinand KC, Pool J, Weitzman R, Purkayastha D, Townsend R. Peripheral and central blood pressure responses of combination aliskiren/hydrochlorothiazide and amlodipine monotherapy in African American patients with stage 2 hypertension: the ATLAAST trial. J Clin Hypertens (Greenwich). 2011 May;13(5):366-75. doi: 10.1111/j.1751-7176.2010.00416.x. Epub 2011 Jan 18.
PubMed 21545398

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An 8 Week Prospective, Multicenter, Randomized, Double-Blind, Active Control, Parallel Group Study to Evaluate the Efficacy and Safety of Aliskiren HCTZ Versus Amlodipine in African American Patients With Stage 2 Hypertension
ClinicalTrials.gov ID: NCT00739596
Acronym / sponsor ID: ATLAAST / CSPP100AUS03
Conditions: Hypertension
Keywords: Hypertension, African American, aliskiren, hydrochlorothiazide, systolic blood pressure, diastolic blood pressure, amlodipine, stage 2
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 332 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jul 2008
Primary completion: Mar 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 22 Aug 2008 (estimated)
Results: Posted 12 Jan 2011

Clinical summary

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

The purpose of the study is to evaluate the efficacy and safety of a fixed dose combination of aliskiren HCTZ versus amlodipine in African American patients with Stage 2 hypertension.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Aliskiren Hydrochlorothiazide (HCTZ)	Experimental	Drug: Aliskiren Hydrochlorothiazide (HCTZ): 8 weeks
Amlodipine	Active comparator	Drug: Amlodipine: 8 weeks

Who may qualify

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

Key inclusion criteria (3 listed)

Patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
Men or women 18 years and older of African American background; self identified
Patients with stage 2 hypertension. Patients must have a MSSBP ≥ 160 mmHg and < 200 mmHg at Visit 5 (randomization)

Key exclusion criteria (14 listed)

Office blood pressure measured by cuff (MSSBP ≥ 200 mmHg and/or MSDBP ≥ 110 mmHg) at any visit.
Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives whichever is longer.
History of hypersensitivity to any of the study drugs or to drugs belonging to the same therapeutic class (CCBs or thiazide diuretics) as the study drugs.
Long QT syndrome or QTc > 450 msec for males and > 470 msec for females at screening.
History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.

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
Aliskiren Hydrochlorothiazide (HCTZ): 8 weeksAliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks	Drug	Aliskiren Hydrochlorothiazide (HCTZ)
Amlodipine: 8 weeksAmlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks	Drug	Amlodipine

Primary outcome

Change in Mean Sitting Systolic Blood Pressure (MSSBP) After 8 Weeks of Treatment
Time frame: Baseline and 8 weeks
To assess the change from baseline in MSSBP after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension.

4 secondary outcomes

Change in Mean Sitting Diastolic Blood Pressure (MSDBP) After 8 Weeks of Treatment
Time frame: Baseline and 8 weeks
Change in Mean Sitting Pulse Pressure (MSPP) After 8 Weeks of Treatment
Time frame: Baseline and 8 weeks
Percentage of Responders After 8 Weeks of Treatment.
Time frame: 8 weeks
Percentage of Participants Achieving BP Control After 8 Weeks of Treatment
Time frame: 8 weeks

Results and safety

Results posted to the registry on 12 Jan 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
Aliskiren Hydrochlorothiazide (HCTZ)	166	141
Amlodipine	166	149

Primary outcome: Change in Mean Sitting Systolic Blood Pressure (MSSBP) After 8 Weeks of Treatment

Time frame: Baseline and 8 weeks. Mean (Standard Deviation). Unit: mm Hg

Measure	Aliskiren HCTZ n = 162	Amlodipine n = 162
Baseline	168.2 (8.49)	168.1 (7.99)
Week 8	138.8 (18.21)	139.1 (14.45)
Change from baseline to Week 8	-29.4 (17.95)	-29.0 (13.17)

Population analysed: The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had at least one valid post-baseline assessment of the primary efficacy variable. Last observation carried forward (LOCF) method was used for replacing missing values with post-baseline assessments.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aliskiren HCTZ	5 of 166 (3%)	0 of 166 (0%)	Not reported
Amlodipine	3 of 166 (1.8%)	0 of 166 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21545398Ferdinand KC, Pool J, Weitzman R, Purkayastha D, Townsend R. Peripheral and central blood pressure responses of combination aliskiren/hydrochlorothiazide and amlodipine monotherapy in African American patients with stage 2 hypertension: the ATLAAST trial. J Clin Hypertens (Greenwich). 2011 May;13(5):366-75. doi: 10.1111/j.1751-7176.2010.00416.x. Epub 2011 Jan 18.

Related trials for Hypertension

Active, not recruiting
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Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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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 4 study testing Aliskiren Hydrochlorothiazide (HCTZ): 8 weeks and Amlodipine: 8 weeks in people with Hypertension, run by Novartis Pharmaceuticals at 1 site in United States.

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 3 inclusion and 14 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 27 Oct 2016. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 12 Jan 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 Systolic Blood Pressure (MSSBP) After 8 Weeks of Treatment (time frame: Baseline and 8 weeks). 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 NCT00739596, 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 27 Oct 2016.