CompletedNCT00772577ATTAINUpdated Mar 11, 2011Results posted

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

A Phase 4 interventional study of Aliskiren Hydrochlorothiazide and Ramipril in Hypertension, sponsored by Novartis. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-03-11.

Sponsored by Novartis · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 386
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

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

Conditions studied

Hypertension

Browse trials for

Hypertension 6,689

Keywords

Hypertension, Obese, aliskiren, hydrochlorothiazide, systolic blood pressure, diastolic blood pressure, ramipril, stage 2

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 386 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

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Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.
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.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 386 participants (actual)

Study arms

Experimental
1
Aliskiren Hydrochlorothiazide(HCTZ)
Drug: Aliskiren Hydrochlorothiazide
Active comparator
2
Ramipril
Drug: Ramipril

Interventions

DrugAliskiren Hydrochlorothiazide
Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
DrugRamipril
Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks

What researchers measure

Primary outcomes

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).
Time frame: Baseline to week 8

Secondary outcomes

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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline to week 8

Results

Posted Mar 2, 2011

Participant flow

Participant flow — Overall Study
Milestone	Aliskiren HCTZ	Ramipril
Started	193	193
Completed	170	170
Not completed	23	23
Withdrew: Adverse event	6	3
Withdrew: Abnormal laboratory values	0	1
Withdrew: Unsatisfactory therapeutic effect	0	8
Withdrew: Patient withdrew consent	8	5
Withdrew: Lost to follow-up	4	3
Withdrew: Administrative problems	2	1
Withdrew: Protocol deviation	3	2

Outcome measures

PrimaryChange 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).

Time frame:: Baseline to week 8
Reported as:: Mean · mm Hg

Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)
mm Hg	Aliskiren HCTZ	Ramipril
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

SecondaryChange 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).

Time frame:: Baseline to week 8
Reported as:: Mean · mm Hg

Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
mm Hg	Aliskiren HCTZ	Ramipril
Baseline	94.3 ± 8.41	96.3 ± 8.48
Week 8	84.2 ± 9.80	92.7 ± 11.07
Change from baseline to week 8	-10.1 ± 9.04	-3.6 ± 9.48

SecondaryPercentage 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.

Time frame:: 8 weeks
Reported as:: Number · Percentage of patients

Percentage of Patients Achieving Blood Pressure Control During 8 Weeks
Percentage of patients	Aliskiren HCTZ	Ramipril
Percentage of Patients Achieving Blood Pressure Control During 8 Weeks	63.7	30.0

SecondaryPercentage 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.

Time frame:: 8 weeks
Reported as:: Number · Percentage of patients

Percentage of Responders (MSSBP < 140 mmHg or ≥ 20 mmHg Decrease From Baseline in MSSBP)
Percentage of patients	Aliskiren HCTZ	Ramipril
Percentage of Responders (MSSBP < 140 mmHg or ≥ 20 mmHg Decrease From Baseline in MSSBP)	87.9	63.2

SecondaryChange 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).

Time frame:: Baseline to week 8
Reported as:: Mean · mm Hg

Change From Baseline in Mean Sitting Pulse Pressure (MSPP)
mm Hg	Aliskiren HCTZ	Ramipril
Baseline	72.7 ± 10.44	71.9 ± 9.85
Week 8	54.7 ± 13.87	58.9 ± 13.98
Change from baseline to week 8	-18.0 ± 12.14	-13.0 ± 12.12

Adverse events

Collected over 8 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Aliskiren HCTZ	—	4/193 (2.1%)	14/193 (7.3%)
Ramipril	—	2/193 (1%)	17/193 (8.8%)

Most frequent serious events

Most frequent serious events
Event	Aliskiren HCTZ	Ramipril
PancreatitisGastrointestinal disorders	1/193	0/193
Chest painGeneral disorders	1/193	0/193
Non-cardiac chest painGeneral disorders	1/193	0/193
DehydrationMetabolism and nutrition disorders	1/193	0/193
ConvulsionNervous system disorders	0/193	1/193
PollakiuriaRenal and urinary disorders	1/193	0/193
Deep vein thrombosisVascular disorders	1/193	0/193
HypertensionVascular disorders	0/193	1/193

Most frequent other events

Most frequent other events
Event	Aliskiren HCTZ	Ramipril
HeadacheNervous system disorders	14/193	17/193

Baseline characteristics

Age Continuous
Age Continuous(years)	Aliskiren HCTZ	Ramipril	Total
Mean	55.4 ± 11.15	54.4 ± 10.90	54.9 ± 11.02

Sex: Female, Male
Sex: Female, Male(Participants)	Aliskiren HCTZ	Ramipril	Total
Female	107	99	206
Male	86	94	180

Study locations

6 sites

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

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 11, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00772577
Lead sponsor: Novartis
First posted: Oct 15, 2008
Start date: Aug 2008
Primary completion: Mar 2009
Completion: Mar 2009
Results posted: Mar 2, 2011
Last update: Mar 11, 2011

Study contacts

Novartis

study director · Novartis

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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