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

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ClinicalTrials.gov Identifier: NCT00705575
Recruitment Status : Completed
First Posted : June 26, 2008
Results First Posted : January 21, 2011
Last Update Posted : May 30, 2011
Sponsor:
Information provided by:
Novartis

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg)
Drug: Aliskiren (300 mg)

  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/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

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 
Overall Participants Analyzed 
[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

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) ]

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

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 ]

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 ]


  Serious Adverse Events


  Other Adverse Events


  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.


  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:
unchecked 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.
unchecked 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.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862 778-8300



Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00705575     History of Changes
Other Study ID Numbers: CSPP100A2353
First Submitted: June 23, 2008
First Posted: June 26, 2008
Results First Submitted: December 22, 2010
Results First Posted: January 21, 2011
Last Update Posted: May 30, 2011