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:
Novartis
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00705575
First received: June 23, 2008
Last updated: May 24, 2011
Last verified: May 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg) Drug: Aliskiren (300 mg) |
Phase 3 |
| 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 |
| 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- 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) ] [ Designated as safety issue: No ]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:
- Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 8 [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]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.
- Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 8 and to Week 12 [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: No ]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.
| Enrollment: | 688 |
| Study Start Date: | June 2008 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
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) |
Keywords provided by Novartis:
|
Essential Hypertension Stage II |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Hydrochlorothiazide Diuretics Natriuretic Agents Physiological Effects of Drugs |
Pharmacologic Actions Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013