Aliskiren in Combination With Losartan Compared to Losartan on the Regression of Left Ventricular Hypertrophy in Overweight Patients With Essential Hypertension (ALLAY)

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00219141

First received: September 12, 2005

Last updated: May 20, 2011

Last verified: May 2011

History of Changes

Results First Received: January 11, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Conditions:	Hypertension Left Ventricular Hypertrophy Overweight
Interventions:	Drug: Aliskiren 150/300 mg Drug: Losartan 50/100 mg Drug: Aliskiren placebo Drug: Losartan 50/100 mg placebo

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Aliskiren 300 mg	Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
Losartan 100 mg	Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
Aliskiren/Losartan 300/100 mg	Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.

Participant Flow: Overall Study

	Aliskiren 300 mg	Losartan 100 mg	Aliskiren/Losartan 300/100 mg
STARTED	154	152	154
COMPLETED	140	131	142
NOT COMPLETED	14	21	12
Adverse Event	4	10	5
Lack of Efficacy	3	2	0
Administrative problems	0	1	0
Lost to Follow-up	2	4	1
Protocol Violation	3	1	1
Withdrawal by Subject	1	3	5
Condition no longer requires study drug	1	0	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Aliskiren 300 mg	Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
Losartan 100 mg	Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
Aliskiren/Losartan 300/100 mg	Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
Total	Total of all reporting groups

Baseline Measures

	Aliskiren 300 mg	Losartan 100 mg	Aliskiren/Losartan 300/100 mg	Total
Number of Participants [units: participants]	154	152	154	460
Age [units: years] Mean ± Standard Deviation	58.4 ± 9.61	59.2 ± 11.00	58.8 ± 10.62	58.8 ± 10.41
Gender [units: participants]
Female	42	35	35	112
Male	112	117	119	348

Outcome Measures

Show All Outcome Measures

1. Primary:

Change in Left Ventricular Mass Index (LVMI) From Baseline to End of Study (Week 36) [ Time Frame: Baseline to end of study (Week 36) ]

Show Outcome Measure 1

2. Secondary:

Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Mass Index as Measured by MRI From Baseline to End of Study (Week 36) [ Time Frame: Baseline to end of study (Week 36) ]

Show Outcome Measure 2

3. Secondary:

Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular End Diastolic Volume as Measured by MRI From Baseline to End of Study (Week 36) [ Time Frame: Baseline to end of study (Week 36) ]

Show Outcome Measure 3

4. Secondary:

Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular End Systolic Volume as Measured by MRI From Baseline to End of Study (Week 36) [ Time Frame: Baseline to end of study (Week 36) ]

Show Outcome Measure 4

5. Secondary:

Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Anteroseptal Wall Thickness as Measured by MRI From Baseline to End of Study (Week 36) [ Time Frame: Baseline to end of study (Week 36) ]

Show Outcome Measure 5

6. Secondary:

Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Inferolateral Wall Thickness as Measured by MRI From Baseline to End of Study (Week 36) [ Time Frame: Baseline to end of study (Week 36) ]

Show Outcome Measure 6

7. Secondary:

Change in the Left Ventricular Hypertrophy (LVH) Parameter Diameter of Ascending Aorta as Measured by MRI From Baseline to End of Study (Week 36) [ Time Frame: Baseline to end of study (Week 36) ]

Show Outcome Measure 7

8. Secondary:

Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular End Diastolic Mass as Measured by MRI From Baseline to End of Study (Week 36) [ Time Frame: Baseline to end of study (Week 36) ]

Show Outcome Measure 8

9. Secondary:

Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Ejection Fraction as Measured by MRI From Baseline to End of Study (Week 36) [ Time Frame: Baseline to end of study (Week 36) ]

Show Outcome Measure 9

10. Secondary:

Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Stroke Volume as Measured by MRI From Baseline to End of Study (Week 36) [ Time Frame: Baseline to end of study (Week 36) ]

Show Outcome Measure 10

11. Secondary:

Change in the Left Ventricular Hypertrophy (LVH) Parameter Sokolow-Lyon Voltage as Measured by Electrocardiogram From Baseline to End of Study (Week 36) [ Time Frame: Baseline to end of study (Week 36) ]

Show Outcome Measure 11

12. Secondary:

Change in the Left Ventricular Hypertrophy (LVH) Parameter Cornell Voltage Duration Product as Measured by Electrocardiogram From Baseline to End of Study (Week 36) [ Time Frame: Baseline to end of study (Week 36) ]

Show Outcome Measure 12

13. Secondary:

Change From Baseline in Mean 24-hour Ambulatory Diastolic and Systolic Blood Pressure From Baseline to the End of the Study (Week 36) [ Time Frame: Baseline the end of study (Week 36) ]

Show Outcome Measure 13

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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
No text entered.

Results Point of Contact:

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

No publications provided by Novartis

Publications automatically indexed to this study:

Pouleur AC, Uno H, Prescott MF, Desai A, Appelbaum E, Lukashevich V, Smith BA, Dahlöf B, Solomon SD; ALLAY Investigators. Suppression of aldosterone mediates regression of left ventricular hypertrophy in patients with hypertension. J Renin Angiotensin Aldosterone Syst. 2011 Dec;12(4):483-90. Epub 2011 Jul 11.

Responsible Party:	Novartis Pharmaceuticals, External Affairs
ClinicalTrials.gov Identifier:	NCT00219141 History of Changes
Other Study ID Numbers:	CSPP100A2316
Study First Received:	September 12, 2005
Results First Received:	January 11, 2011
Last Updated:	May 20, 2011
Health Authority:	United States: Food and Drug Administration Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

To Top