Phase 3 N=186 Treatment

Safety and Efficacy of Aliskiren + Hydrochlorothiazide (± Amlodipine 5 mg) in Patients With Moderate Hypertension

Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT00867490 ↗

Enrolled (actual)

186

Serious AEs

0.8%

Results posted

Feb 2011

Primary outcome: Primary: Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study — -3.12 mmHg

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Candesartan+HCTZ - Phase 1 (Drug); Aliskiren+HCTZ - Phase 2 (Drug); Aliskiren+HCTZ+amlodipine - Phase 3 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis
Primary completion: Aug 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study	-3.12	—
PRIMARY Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study	-5.87	—
SECONDARY Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study	-2.81	—
SECONDARY Change in Sitting Pulse Pressure During the Core Phase of the Study	0.31	—
SECONDARY Change in Sitting Pulse Rate During the Core Phase of the Study	0.27	—
SECONDARY Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study	54.1; 44.3	—
SECONDARY Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study	54.1; 47.5	—
SECONDARY Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study	-9.20	—
SECONDARY Change in Sitting Pulse Pressure During the Extension Phase of the Study	-3.33	—
SECONDARY Change in Sitting Pulse Rate During the Extension Phase of the Study	0.03	—
SECONDARY Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study	54.1; 44.3	—
SECONDARY Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study	54.1; 47.5	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00867490). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.