HypertensionPhase 4ATTAINNCT00772577

Study of the Efficacy and Safety of Aliskiren HCTZ vs Ramipril in Obese Patients (BMI ≥ 30) With Stage 2 Hypertension

A Phase 4 study testing Aliskiren Hydrochlorothiazide and Ramipril in people with Hypertension, run by Novartis at 6 sites 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

Study to Evaluate the Efficacy and Safety of Aliskiren Hydrochlorothiazide (HCTZ) vs Ramipril in Obese patients (BMI ≥ 30) 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 and Ramipril
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 386 participants
Where: 6 sitesUnited States
Study dates: Aug 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.
Male or female outpatients, 18 years of age and older.
Patients with Stage 2 hypertension. Patients must have a MSSBP ≥ 160 mmHg and < 200 mmHg at Study Visit 5 (randomization).
Patients must have a BMI ≥ 30 kg/m2 but ≤ 45 kg/m2.

Who cannot join

Office blood pressure measured by cuff (MSDBP ≥ 110 mmHg and/or MSSBP ≥ 200 mmHg) at any visit.
Use of other investigational drugs within 30 days of enrollment, or 5 half-lives, which ever is longer.
Use of aliskiren and/or a fixed dose combination of aliskiren HCTZ or participation in a clinical trial that had aliskiren and/or aliskiren HCTZ as treatment within 30 days of Visit 1.
History of hypersensitivity to any of the study drugs or to drugs belonging to the same therapeutic class (ACE inhibitors or renin inhibitors) as the study drugs.
History or evidence of a secondary form of hypertension.
Refractory hypertension, defined as, unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90 mmHg). Therapy with a fixed dose combination of two active substances represent two drugs.

Show all 9Show fewer

Patients on 4 or more antihypertensive medications.
Long QT syndrome or QTc > 450 msec for males and > 470 msec for females at screening.
Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Investigative Site
Beverly Hills, California
Investigative Site
Columbia, South Carolina
Investigative Site
Conyers, Georgia
Investigative Site
Houston, Texas
Investigative Site
Lexington, Kentucky
Investigative Site
Santa Ana, California

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 vs Ramipril in Obese Patients (BMI ≥ 30) With Stage 2 Hypertension

Study to Evaluate the Efficacy and Safety of Aliskiren Hydrochlorothiazide (HCTZ) vs Ramipril in Obese patients (BMI ≥ 30) with Stage 2 Hypertension

Conditions: Hypertension
Being tested: Aliskiren Hydrochlorothiazide, Ramipril
Keywords: Hypertension, Obese, aliskiren, hydrochlorothiazide, systolic blood pressure, diastolic blood pressure, ramipril, stage 2
Medical subject headings: Hypertension, Obesity

What participants receive

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

Aliskiren HydrochlorothiazideDrug
Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
RamiprilDrug
Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks

Study groups in NCT00772577
Study group	Role	What they receive
1	Experimental	Aliskiren Hydrochlorothiazide(HCTZ) Receives: Drug: Aliskiren Hydrochlorothiazide
2	Active comparator	Ramipril Receives: Drug: Ramipril

What is being measured

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

Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)
To assess the change in mean sitting systolic blood pressure (MSSBP) after 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg).
Measured: Baseline to week 8

Secondary outcomes (4)

Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
To evaluate the difference in mean sitting diastolic blood pressure (MSDBP) after 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg).
Measured: Baseline to week 8
Percentage of Patients Achieving Blood Pressure Control During 8 Weeks
The percentage of patients achieving the Blood Pressure control (defined as patients achieving a MSSBP < 140 mm Hg and MSDBP < 90 mm Hg) during 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg). Data presented are cumulative. Cumulative refers to achieving blood pressure control before or at the 8 week visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.
Measured: 8 weeks
Percentage of Responders (MSSBP < 140 mmHg or ≥ 20 mmHg Decrease From Baseline in MSSBP)
To compare the percentage of responders (as defined by patients with MSSBP < 140 mm Hg or a decrease from baseline ≥ 20 mm Hg) during 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg). Data presented are cumulative. Cumulative refers to achieving the response before or at the 8 week visit. If response occurred more than once, only the first occurrence was counted.
Measured: 8 weeks
Change From Baseline in Mean Sitting Pulse Pressure (MSPP)
To compare the change in mean sitting pulse pressure (MSPP) after 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg).
Measured: Baseline to week 8

Timeline

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

Aug 2008Mar 2009

First posted15 Oct 2008 (estimated)
Study startAug 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.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 386 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00772577
Sponsor's protocol ID: CSPP100AUS07
Acronym: ATTAIN
Status last verified: Mar 2011
First submitted: 10 Oct 2008
Last updated: 11 Mar 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 11 Mar 2011. 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 vs Ramipril in Obese Patients (BMI ≥ 30) With Stage 2 Hypertension
ClinicalTrials.gov ID: NCT00772577
Acronym / sponsor ID: ATTAIN / CSPP100AUS07
Conditions: Hypertension
Keywords: Hypertension, Obese, aliskiren, hydrochlorothiazide, systolic blood pressure, diastolic blood pressure, ramipril, stage 2
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 386 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Aug 2008
Primary completion: Mar 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 15 Oct 2008 (estimated)
Results: Posted 2 Mar 2011

Clinical summary

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

Study to Evaluate the Efficacy and Safety of Aliskiren Hydrochlorothiazide (HCTZ) vs Ramipril in Obese patients (BMI ≥ 30) with Stage 2 Hypertension

Study design

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

Arm	Type	Receives
1	Experimental	Drug: Aliskiren HydrochlorothiazideAliskiren Hydrochlorothiazide(HCTZ)
2	Active comparator	Drug: RamiprilRamipril

Who may qualify

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

Key inclusion criteria (4 listed)

Patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
Male or female outpatients, 18 years of age and older.
Patients with Stage 2 hypertension. Patients must have a MSSBP ≥ 160 mmHg and < 200 mmHg at Study Visit 5 (randomization).
Patients must have a BMI ≥ 30 kg/m2 but ≤ 45 kg/m2.

Key exclusion criteria (9 listed)

Office blood pressure measured by cuff (MSDBP ≥ 110 mmHg and/or MSSBP ≥ 200 mmHg) at any visit.
Use of other investigational drugs within 30 days of enrollment, or 5 half-lives, which ever is longer.
Use of aliskiren and/or a fixed dose combination of aliskiren HCTZ or participation in a clinical trial that had aliskiren and/or aliskiren HCTZ as treatment within 30 days of Visit 1.
History of hypersensitivity to any of the study drugs or to drugs belonging to the same therapeutic class (ACE inhibitors or renin inhibitors) as the study drugs.
History or evidence of a secondary form of hypertension.

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 HydrochlorothiazideAliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks	Drug	1
RamiprilRamipril 5mg: 1 week; Ramipril 10 mg: 7 weeks	Drug	2

Primary outcome

Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)
Time frame: Baseline to week 8
To assess the change in mean sitting systolic blood pressure (MSSBP) after 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg).

4 secondary outcomes

Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
Time frame: Baseline to week 8
Percentage of Patients Achieving Blood Pressure Control During 8 Weeks
Time frame: 8 weeks
Percentage of Responders (MSSBP < 140 mmHg or ≥ 20 mmHg Decrease From Baseline in MSSBP)
Time frame: 8 weeks
Change From Baseline in Mean Sitting Pulse Pressure (MSPP)
Time frame: Baseline to week 8

Results and safety

Results posted to the registry on 2 Mar 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 HCTZ	193	170
Ramipril	193	170

Primary outcome: Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)

Time frame: Baseline to week 8. Mean (Standard Deviation). Unit: mm Hg

Measure	Aliskiren HCTZ n = 190	Ramipril n = 190
Baseline	167.0 (7.05)	168.2 (7.86)
Week 8	138.9 (16.56)	151.6 (17.44)
Change from baseline to week 8	-28.1 (15.54)	-16.6 (14.76)

Population analysed: Intent-to-treat population (consisted of all patients who received at least one dose of study medication and had at least one valid post baseline assessment of primary efficacy variable). Last Observation Carried Forward (LOCF)

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	4 of 193 (2.1%)	14 of 193 (7.3%)	Not reported
Ramipril	2 of 193 (1%)	17 of 193 (8.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Chronic Kidney Disease, Hypertension (HTN)
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Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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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

6 sites 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 and Ramipril in people with Hypertension, run by Novartis at 6 sites 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 4 inclusion and 9 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 11 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 2 Mar 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 From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) (time frame: Baseline to week 8). 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 NCT00772577.

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 11 Mar 2011.