Clinical trial NCT00386607: A Safety and Tolerability Study of the Combination of Aliskiren/Valsartan in Patients With High Blood Pressure, Followed by Long-term Safety and Tolerability of Aliskiren, Valsartan and Hydrochlorothiazide.
Official title: A 54-week, Open-label, Multicenter Study to Assess the Long-term Safety and Tolerability of the Combination of Aliskiren 300 mg /Valsartan 320 mg in Patients With Essential Hypertension Followed by a 26 Week Open-label Extension to Assess the Long-term Safety and Tolerability of the Triple Combination of Aliskiren/Valsartan/Hydrochlorothiazide(HCTZ)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension, aliskiren, valsartan, HCTZ, blood pressure
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-10-11
Enrollment: 601
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: Assessment of the long-term safety and tolerability of the combination of aliskiren and valsartan (300 mg/ 320 mg) in patients with high blood pressure,followed by assessment of long-term safety and tolerability of the combination of aliskiren/valsartan/Hydrochlorothiazide(HCTZ).


Eligibility criteria: Inclusion Criteria: -

* Male and female outpatients 18 years of age and older.
* For newly diagnosed/untreated patients with essential hypertension defined as msDBP ≥ 90 and \< 110 mmHg at Visit 1 and Visit 4
* For previously treated patients with essential hypertension defined as msDBP ≥ 90 and \< 110 mmHg after 2 to 4 weeks of washout (Visit 4)
* Patients who were eligible and able to participate in the study and who consented to do so after the purpose and nature of the investigation had been clearly explained to them (written informed consent).

Exclusion Criteria:

* Severe hypertension (msDBP ≥ 110 mmHg and/or msSBP ≥ 180 mmHg)
* Women of child-bearing potential, unless they met definition of post-menopausal or were using acceptable methods of contraception.
* History or evidence of a secondary form of hypertension.
* History of hypertensive encephalopathy or cerebrovascular accident.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Overall Percentage of Patients With Adverse Events
timeFrame: Month 12
measure: Overall Percentage of Patients With Adverse Events
timeFrame: Month 18
Secondary outcomes:
measure: Change From Baseline in Mean Sitting Diastolic Blood Pressure.
timeFrame: Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54
measure: Change From Baseline in Mean Sitting Systolic Blood Pressure.
timeFrame: Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41 and 54
measure: Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg
timeFrame: .Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54
measure: Change From Baseline in Mean Sitting Diastolic Blood Pressure
timeFrame: Baseline and Month 18
measure: Change From Baseline in Mean Sitting Systolic Blood Pressure
timeFrame: Baseline and Month 18
measure: Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg in Extension Treatment
timeFrame: Month 18
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Investigative Centers
state: California
city: Canada
country: Canada
facility: Investigative Centers
city: Germany
country: Germany
facility: Investigative Centers
city: Netherlands
country: Netherlands
facility: Investigative Centers
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Chrysant SG, Murray AV, Hoppe UC, Dattani D, Patel S, Ritter S, Zhang J. Long-term safety and efficacy of aliskiren and valsartan combination with or without the addition of HCT in patients with hypertension. Curr Med Res Opin. 2010 Dec;26(12):2841-9. doi: 10.1185/03007995.2010.528282. Epub 2010 Nov 9.