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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:

Study Description
Brief Summary:
This study will compare the efficacy and safety of once daily dosing of aliskiren monotherapy to once daily dosing of aliskiren and hydrochlorothiazide combination therapy in patients with Stage II hypertension over a period of 12 weeks.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg) Drug: Aliskiren (300 mg) Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 688 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A 12 Week, Double-blind, Randomized, Parallel Group, Multi-center Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren 300 mg and Hydrochlorothiazide 25 mg Compared to Aliskiren 300 mg in Patients With Stage II Hypertension
Study Start Date : June 2008
Primary Completion Date : April 2009
Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg) Drug: Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg)
During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week.
Active Comparator: Aliskiren (300 mg) Drug: 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.


Outcome Measures

Primary Outcome Measures :
  1. 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) ]
    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.


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

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

  3. 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 ]
    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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatients ≥18 years of age.
  • Patients with a diagnosis of Stage II hypertension, defined as mean sitting Systolic Blood Pressure (msSBP) ≥ 160 mmHg and < 180 mmHg at Visit 2.

Exclusion Criteria:

  • Severe hypertension defined as msSBP ≥ 180 mmHg and/or mean sitting Diastolic Blood Pressure (msDBP) ≥ 110 mmHg.
  • Secondary form of hypertension.
  • Current diagnosis of heart failure (New York Heart Association [NYHA] Class II-IV).
  • Current angina pectoris requiring pharmacological therapy (other than stable doses of oral or topical nitrates).
  • Second or third degree heart block without a pacemaker.
  • Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, atrial fibrillation or atrial flutter, during the 12 months prior to Visit 1.
  • Clinically significant valvular heart disease.
  • Previous history of hypertensive encephalopathy or stroke, Transcient Ischemic Attack (TIA), heart attack, coronary bypass surgery or any PCI.
  • Known Keith-Wagener grade III or IV hypertensive retinopathy.
  • In the month prior to Visit 1, patients on combination antihypertensive therapy that includes more than 2 classes of antihypertensive medications.
  • Patients on combined antihypertensive medication that contain two classes of antihypertensive medications are considered to take two antihypertensive medications.
  • Inability to discontinue prior antihypertensive or other CV medications as required by the protocol.
  • Patients with Type 1 diabetes mellitus.
  • Patients with Type 2 diabetes mellitus not well controlled .
  • Elevated Serum potassium (over 5.3 mEq/L (mmol/L).
  • Any surgical or medical condition or the use of any medication which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs.

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00705575


Locations
United States, New Jersey
Investigative Site
East Hanover, New Jersey, United States, 07936
Argentina
Investigative Site
Buenos Aires, Argentina
Ecuador
Investigative Site
Quito, Ecuador
Germany
Investigative Site
Berlin, Germany
Guatemala
Investigative Site
Guatemala City, Guatemala
Italy
Investigative Site
Rome, Italy
Switzerland
Investigative Site
Basel, Switzerland
Turkey
Investigative Site
Ankara, Turkey
Sponsors and Collaborators
Novartis
More Information

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00705575     History of Changes
Other Study ID Numbers: CSPP100A2353
First Posted: June 26, 2008    Key Record Dates
Results First Posted: January 21, 2011
Last Update Posted: May 30, 2011
Last Verified: May 2011

Keywords provided by Novartis:
Essential Hypertension
Stage II

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action