Efficacy and Safety of the Combination Aliskiren (300 mg) and Hydrochlorothiazide (25mg) to Aliskiren (300mg) Monotherapy in Patients With Staged II Hypertension (ACQUIRE)

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00705575

First received: June 23, 2008

Last updated: May 24, 2011

Last verified: May 2011

History of Changes

Results First Received: December 22, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Condition:	Hypertension
Interventions:	Drug: Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg) Drug: Aliskiren (300 mg)

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/Hydrochlorothiazide (HCTZ) (300/25 mg)	During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
Aliskiren (300 mg)	During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.

Participant Flow: Overall Study

	Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)	Aliskiren (300 mg)
STARTED	349	339
COMPLETED	326	293
NOT COMPLETED	23	46
Abnormal laboratory value(s)	0	3
Abnormal test procedure result(s)	2	12
Adverse Event	11	15
Lost to Follow-up	3	4
Protocol Violation	2	2
Withdrawal by Subject	5	10

Baseline Characteristics

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Reporting Groups

	Description
Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)	During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
Aliskiren (300 mg)	During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
Total	Total of all reporting groups

Baseline Measures

	Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)	Aliskiren (300 mg)	Total
Number of Participants [units: participants]	349	339	688
Age [units: years] Mean ± Standard Deviation	57.4 ± 10.33	56.4 ± 10.73	56.9 ± 10.53
Gender [units: participants]
Female	169	172	341
Male	180	167	347

Outcome Measures

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1. Primary:

Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 12) [ Time Frame: Baseline to end of study (Week 12) ]

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2. Secondary:

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

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3. Secondary:

Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 8 and to Week 12 [ Time Frame: Baseline to Week 12 ]

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4. Secondary:

Percentage of Patients Achieving the Target Blood Pressure (msSBP < 140 mm Hg and msDBP < 90 mm Hg, and msSBP < 130 mm Hg and msDBP < 80 mm Hg for Diabetics) at Week 8 and Week 12 [ Time Frame: Baseline to Week 12 ]

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Serious Adverse Events

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Other Adverse Events

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Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)	During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
Aliskiren (300 mg)	During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.

Other Adverse Events

	Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)	Aliskiren (300 mg)
Total, other (not including serious) adverse events
# participants affected / at risk	27/349	34/339
Nervous system disorders
Dizziness ^{† 1}
# participants affected / at risk	19/349 (5.44%)	10/339 (2.95%)
Headache ^{† 1}
# participants affected / at risk	14/349 (4.01%)	29/339 (8.55%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA

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:	Novartis
ClinicalTrials.gov Identifier:	NCT00705575 History of Changes
Other Study ID Numbers:	CSPP100A2353
Study First Received:	June 23, 2008
Results First Received:	December 22, 2010
Last Updated:	May 24, 2011
Health Authority:	United States: Food and Drug Administration Germany: Federal Institute for Drugs and Medical Devices Italy: The Italian Medicines Agency Switzerland: Swissmedic Turkey: General Directorate of Pharmaceuticals and Pharmacy (IEGM - Ilaç ve Eczacilik Genel Müdürlügü) Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Guatemala: MSPAS (Departamento de Regulación de Productos Farmacéuticos y Afines, Ministerio de Salud Pública y Asistencia Social) Ecuador: M&P Instituto Nacional de Higiene y Medicina Tropical (INH)

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