Clinical trial NCT00667719: A Long Term Safety Study to Test the Combination of Aliskiren/ Amlodipine / Hydrochlorothiazide in Participants With Essential Hypertension
Official title: A 28 to 54-week, Open-label, Multicenter Study to Assess the Long-term Safety and Tolerability of the Combination of Aliskiren / Amlodipine / Hydrochlorothiazide in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Hypertension
Keywords: Essential hypertension
High blood pressure
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-04-28
Enrollment: 564
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study tested the safety of the combination of aliskiren/amlodipine/hydrochlorothiazide in participants with essential hypertension.


Eligibility criteria: Inclusion Criteria:

* Outpatients 18 years of age or older
* Male or female participants are eligible.
* Mean sitting diastolic blood pressure (msDBP) and mean sitting systolic blood pressure (msSBP) Requirements:

  * For newly diagnosed/untreated participants, msDBP ≥ 100 and \< 120 millimeters of mercury (mmHg), and/or msSBP ≥ 160 and \< 200 mmHg at Visit 1 and Visit 2.
  * For previously treated participants, msDBP ≥ 100 and \< 120 mmHg, and/or msSBP ≥ 160 and \< 200 mmHg at Visit 2, Visit 3, or Visit 4.
* For participants requiring tapering off their previous antihypertensive medication, they must meet the above criteria and completely discontinue all antihypertensive treatment prior to entering the treatment phase of the study.
* Participants who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).

Exclusion Criteria:

* Inability to discontinue all prior antihypertensive medications safely for a period of 1 week to 4 weeks as required by the protocol.
* Participants on three antihypertensive drugs with msDBP ≥ 110 mmHg and/or msSBP ≥ 180 mmHg at Visit 1.
* Participants on four or more antihypertensive drugs at Visit 1.
* Participants with an msSBP ≥ 200 and msDBP ≥ 120 mmHg anytime during the washout period of the study Visit 1-4 must be discontinued from the study.
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (\>= 5 milli-international units per milliliter mIU/mL).

Primary outcomes:
measure: Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Death
timeFrame: 54 weeks
Secondary outcomes:
measure: Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
timeFrame: Baseline, Weeks 28 and 54 endpoint
measure: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
timeFrame: Baseline, Weeks 28 and 54 endpoints
measure: Percentage of Participants Achieving the Blood Pressure Control Target of <140/90 mmHg
timeFrame: Weeks 28 and 54 endpoints
measure: Percentage of Participants Who Achieved a Blood Pressure Response in Mean Sitting Diastolic Blood Pressure
timeFrame: Weeks 28 and 54 endpoints
measure: Percentage of Participants Who Achieved a Blood Pressure Response in Mean Sitting Systolic Blood Pressure
timeFrame: Weeks 28 and 54 endpoints
Other outcomes:
Locations:
city: Houston
country: United States
facility: Investigative Site
state: Texas
city: Belgium
country: Belgium
facility: Investigative Site
city: Egypt
country: Egypt
facility: Investigative Site
city: Germany
country: Germany
facility: Investigative Site
city: Poland
country: Poland
facility: Investigative Site
city: Slovakia
country: Slovakia
facility: Investigative Site
city: Spain
country: Spain
facility: Investigative Site
city: Turkey
country: Turkey
facility: Investigative Site
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References:
citation: Murray AV, Koenig W, Garcia-Puig J, Patel S, Uddin A, Zhang J. Safety and efficacy of aliskiren/amlodipine/hydrochlorothiazide triple combination in patients with moderate to severe hypertension: a 54-week, open-label study. J Clin Hypertens (Greenwich). 2012 Dec;14(12):821-7. doi: 10.1111/j.1751-7176.2012.00706.x. Epub 2012 Aug 28.