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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)
Enrollment 688
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg) Aliskiren (300 mg)
Hide Arm/Group Description 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. During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
Period Title: Overall Study
Started 349 339
Completed 326 293
Not Completed 23 46
Reason Not Completed
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
Arm/Group Title Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg) Aliskiren (300 mg) Total
Hide Arm/Group Description 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. During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg. Total of all reporting groups
Overall Number of Baseline Participants 349 339 688
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 349 participants 339 participants 688 participants
57.4  (10.33) 56.4  (10.73) 56.9  (10.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 349 participants 339 participants 688 participants
Female
169
  48.4%
172
  50.7%
341
  49.6%
Male
180
  51.6%
167
  49.3%
347
  50.4%
1.Primary Outcome
Title Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 12)
Hide Description At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.
Time Frame Baseline to end of study (Week 12)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All randomized patients. For each patient, the last post-baseline measurement during the double-blind period was carried forward. n = number of patients with non-missing Week 12 measurement or last observation carried forward (LOCF) value.
Arm/Group Title Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg) Aliskiren (300 mg)
Hide Arm/Group Description:
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.
During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
Overall Number of Participants Analyzed 346 335
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-30.01  (1.053) -20.29  (1.067)
2.Secondary Outcome
Title Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 8
Hide Description At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.
Time Frame Baseline to Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All randomized patients. For each patient, the last post-baseline measurement during the double-blind period was carried forward. n = number of patients with non-missing Week 8 measurement or last observation carried forward (LOCF) value.
Arm/Group Title Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg) Aliskiren (300 mg)
Hide Arm/Group Description:
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.
During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
Overall Number of Participants Analyzed 346 335
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-30.09  (1.079) -20.75  (1.094)
3.Secondary Outcome
Title Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 8 and to Week 12
Hide Description At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.
Time Frame Baseline to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All randomized patients. For each patient, the last post-baseline measurement during the double-blind period was carried forward. n = number of patients with non-missing Week 8 or Week 12 measurement or last observation carried forward (LOCF) value.
Arm/Group Title Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg) Aliskiren (300 mg)
Hide Arm/Group Description:
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.
During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
Overall Number of Participants Analyzed 346 335
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
Baseline to Week 8 -13.69  (0.599) -7.99  (0.607)
Baseline to Week 12 -12.64  (0.590) -8.18  (0.598)
4.Secondary Outcome
Title 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
Hide Description At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.
Time Frame Baseline to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All randomized patients. For each patient, the last post-baseline measurement during the double-blind period was carried forward. n = number of patients with non-missing Week 8 or Week 12 measurement or last observation carried forward (LOCF) value.
Arm/Group Title Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg) Aliskiren (300 mg)
Hide Arm/Group Description:
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.
During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
Overall Number of Participants Analyzed 346 335
Measure Type: Number
Unit of Measure: Percentage
Baseline to Week 8 53.5 30.4
Baseline to Week 12 54.6 32.2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg) Aliskiren (300 mg)
Hide Arm/Group Description 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. During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
All-Cause Mortality
Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg) Aliskiren (300 mg)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg) Aliskiren (300 mg)
Affected / at Risk (%) Affected / at Risk (%)
Total   2/349 (0.57%)   4/339 (1.18%) 
Ear and labyrinth disorders     
Vertigo  1  0/349 (0.00%)  1/339 (0.29%) 
Gastrointestinal disorders     
Haemorrhoids  1  1/349 (0.29%)  0/339 (0.00%) 
Injury, poisoning and procedural complications     
Fracture displacement  1  0/349 (0.00%)  1/339 (0.29%) 
Radius fracture  1  0/349 (0.00%)  1/339 (0.29%) 
Tendon rupture  1  1/349 (0.29%)  0/339 (0.00%) 
Renal and urinary disorders     
Nephrolithiasis  1  0/349 (0.00%)  2/339 (0.59%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg) Aliskiren (300 mg)
Affected / at Risk (%) Affected / at Risk (%)
Total   27/349 (7.74%)   34/339 (10.03%) 
Nervous system disorders     
Dizziness  1  19/349 (5.44%)  10/339 (2.95%) 
Headache  1  14/349 (4.01%)  29/339 (8.55%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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 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.
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