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

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

This study has been completed.

Study NCT00772577 Information provided by Novartis

First Received on October 10, 2008. Last Updated on March 8, 2011 History of Changes

Results First Received: December 7, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Hypertension
Interventions:	Drug: Aliskiren Hydrochlorothiazide Drug: Ramipril

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

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

Participant Flow: Overall Study

	Aliskiren HCTZ	Ramipril
STARTED	193	193
COMPLETED	170	170
NOT COMPLETED	23	23
Adverse Event	6	3
Abnormal laboratory values	0	1
Unsatisfactory therapeutic effect	0	8
Patient withdrew consent	8	5
Lost to Follow-up	4	3
Administrative problems	2	1
Protocol Deviation	3	2

Baseline Characteristics

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Reporting Groups

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

Baseline Measures

	Aliskiren HCTZ	Ramipril	Total
Number of Participants [units: participants]	193	193	386
Age [units: years] Mean ± Standard Deviation	55.4 ± 11.15	54.4 ± 10.90	54.9 ± 11.02
Gender [units: participants]
Female	107	99	206
Male	86	94	180

Outcome Measures

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1. Primary:

Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) [ Time Frame: Baseline to week 8 ]

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2. Secondary:

Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) [ Time Frame: Baseline to week 8 ]

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3. Secondary:

Percentage of Patients Achieving Blood Pressure Control During 8 Weeks [ Time Frame: 8 weeks ]

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4. Secondary:

Percentage of Responders (MSSBP < 140 mmHg or ≥ 20 mmHg Decrease From Baseline in MSSBP) [ Time Frame: 8 weeks ]

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5. Secondary:

Change From Baseline in Mean Sitting Pulse Pressure (MSPP) [ Time Frame: Baseline to week 8 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300

No publications provided

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00772577 History of Changes
Other Study ID Numbers:	CSPP100AUS07
Study First Received:	October 10, 2008
Results First Received:	December 7, 2010
Last Updated:	March 8, 2011
Health Authority:	United States: Food and Drug Administration