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

Hypertension Clinical Trial

— ACQUIRE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00705575
• Other study ID #: CSPP100A2353
• Status: Completed
• Phase: Phase 3
• First received: June 23, 2008
• Last updated: May 24, 2011
• Start date: June 2008
• Est. completion date: April 2009

Study information

• Verified date: May 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesItaly: The Italian Medicines AgencySwitzerland: SwissmedicTurkey: General Directorate of Pharmaceuticals and Pharmacy (IEGM - Ilaç ve Eczacilik Genel Müdürlügü)Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaGuatemala: 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)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 688
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg)
During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week.
• 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.

Locations

Country	Name	City	State
Argentina	Investigative Site	Buenos Aires
Ecuador	Investigative Site	Quito
Germany	Investigative Site	Berlin
Guatemala	Investigative Site	Guatemala City
Italy	Investigative Site	Rome
Switzerland	Investigative Site	Basel
Turkey	Investigative Site	Ankara
United States	Investigative Site	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Argentina,  Ecuador,  Germany,  Guatemala,  Italy,  Switzerland,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean Sitting Systolic Blood Pressure (msSBP) From 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.	Baseline to end of study (Week 12)	No
Secondary	Change in Mean Sitting Systolic Blood Pressure (msSBP) From 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.	Baseline to Week 8	No
Secondary	Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 8 and 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.	Baseline to Week 12	No
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	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.	Baseline to Week 12	No