Clinical trial NCT00867490: Safety and Efficacy of Aliskiren + Hydrochlorothiazide (± Amlodipine 5 mg) in Patients With Moderate Hypertension
Official title: An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of a 4 Week Therapy With Aliskiren 300 mg Plus Hydrochlorothiazide 25 mg in Hypertensive Patients Not Adequately Responding to a 4 Week Therapy With Candesartan 32 mg Plus Hydrochlorothiazide 25 mg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension
aliskiren
cardiovascular diseases
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-03-23
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and efficacy of aliskiren plus hydrochlorothiazide (HCTZ) in patients who do not achieve controlled blood pressure levels after treatment with another specified antihypertensive medication. There was an optional study extension for the first eligible 60 patients who wanted to participate that contains the triple therapy with amlodipine 5 mg and aliskiren 300 mg plus HCTZ 25 mg.

Detailed description: Title of study extension: An open-label, multicenter extension to evaluate the efficacy and safety of a 4 week therapy with amlodipine 5 mg and aliskiren 300 mg plus HCTZ 25 mg in hypertensive patients not adequately responding to a 4 week therapy each with the combinations of candesartan 32 mg plus hydrochlorothiazide 25 mg followed by aliskiren 300mg plus hydrochlorothiazide 25 mg

Eligibility criteria: Inclusion Criteria for Core Study:

- Patients with mean sitting diastolic blood pressure ≥ 100 mmHg and \< 110 mmHg

Inclusion criteria for the Extension:

- msSBP ≥ 140 mm Hg and/or msDBP ≥ 90 mm Hg at Visit 5 of the core study

Exclusion Criteria for Core Study:

* Patients with mean diastolic blood pressure ≥ 110 mmHg or mean systolic blood pressure ≥ 180 mmHg
* Patients with prior stroke, hypertensive encephalopathy or heart attack
* Patients with type 1 diabetes mellitus
* Patients with type 2 diabetes mellitus with poor glucose control

Exclusion criteria for the Extension:

* Premature discontinuation in the core study or failure to comply with the core study protocol
* History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures, known or suspected contraindications to diuretics as described in the SmPC (particularly amlodipine 5 mg), e.g. severe hypotension, shock - including cardiogenic shock, obstructions impairing the flow out of the left ventricle (e.g. significant aortic stenosis)
* Any patient that the investigator decides should not participate in the extension study for medical reasons

Other protocol-defined inclusion/exclusion criteria applied to the study.

Primary outcomes:
measure: Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study
timeFrame: Baseline Phase 2 to end of Phase 2
measure: Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study
timeFrame: Baseline Phase 3 to end of Phase 3
Secondary outcomes:
measure: Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study
timeFrame: Baseline Phase 2 to end of Phase 2
measure: Change in Sitting Pulse Pressure During the Core Phase of the Study
timeFrame: Baseline Phase 2 to end of Phase 2
measure: Change in Sitting Pulse Rate During the Core Phase of the Study
timeFrame: Baseline Phase 2 to end of Phase 2
measure: Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study
timeFrame: Baseline Phase 2 to end of Phase 2
measure: Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study
timeFrame: Baseline Phase 2 to end of Phase 2
measure: Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study
timeFrame: Baseline Phase 3 to end of Phase 3
measure: Change in Sitting Pulse Pressure During the Extension Phase of the Study
timeFrame: Baseline Phase 3 to end of Phase 3
measure: Change in Sitting Pulse Rate During the Extension Phase of the Study
timeFrame: Baseline Phase 3 to end of Phase 3
measure: Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study
timeFrame: Baseline Phase 3 to end of Phase 3
measure: Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study
timeFrame: Baseline Phase 3 to end of Phase 3
Other outcomes:
Locations:
city: Chemnitz
country: Germany
facility: Investigative Site
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
citation: Schweizer J, Ulmer HJ, Benduhn H, Klebs S. Efficacy and tolerability of aliskiren 300 mg/hydrochlorothiazide 25 mg (+/- amlodipine 5 mg) in hypertensive patients not controlled by candesartan 32 mg plus HCT 25 mg. Curr Med Res Opin. 2011 Jan;27(1):131-40. doi: 10.1185/03007995.2010.537318. Epub 2010 Nov 30.