Clinical trial NCT00327587: 8-week Study to Evaluate Safety and Efficacy of Various Combinations of Valsartan, HCTZ, and Amlodipine in Patients With Moderate to Severe Hypertension
Official title: An 8-week, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Valsartan/HCTZ/Amlodipine Compared to Valsartan/HCTZ, Valsartan/Amlodipine, and HCTZ/Amlodipine in Patients With Moderate to Severe Hypertension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: hypertension
valsartan
amlodipine
HCTZ
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-05-18
Enrollment: 2279
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and efficacy of the various combinations of valsartan, HCTZ, and amlodipine in patients with moderate to severe hypertension.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of moderate to severe hypertension (MSDBP ≥ 100 mmHg and \< 120 mmHg, MSSBP ≥ 145 mmHg and \< 200 mmHg).

Exclusion Criteria:

* Patients on two or more antihypertensive drugs with MSSBP ≥ 180 mmHg and/or MSDBP ≥ 110 mmHg at Visit 1.
* Patients on three or more antihypertensive drugs with MSDBP ≥ 90 mmHg and \< 110 mmHg, and/or MSSBP ≥ 140 mmHg and \< 180 mmHg at Visit 1.
* Patients on four or more antihypertensive drugs at Visit 1.
* Arm circumference \> 42 cm for patients participating in ABPM.

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Change from baseline diastolic blood pressure after 8 weeks
measure: Change from baseline systolic blood pressure after 8 weeks
Secondary outcomes:
measure: Blood pressure less than 140/90 mmHg after 8 weeks
measure: Systolic blood pressure less than 140 mmHg or diastolic blood pressure less than 90 mmHg after 8 weeks
measure: Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease after 8 weeks or systolic blood pressure less than 140 mmHg or at least a 15 mmHg decrease after 8 weeks
measure: Ambulatory blood pressure and standing systolic and diastolic blood pressure measurements
measure: Adverse events, serious adverse events, laboratory values, physical examinations, and vital signs for up to 8 weeks
Other outcomes:
Locations:
city: E. Hanover
country: United States
facility: Novartis Pharmaceuticals Corporation
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
References:
citation: Calhoun DA, Lacourciere Y, Crikelair N, Jia Y, Glazer RD. Effects of demographics on the antihypertensive efficacy of triple therapy with amlodipine, valsartan, and hydrochlorothiazide for moderate to severe hypertension. Curr Med Res Opin. 2013 Aug;29(8):901-10. doi: 10.1185/03007995.2013.803057. Epub 2013 Jul 1.
citation: Lacourciere Y, Crikelair N, Glazer RD, Yen J, Calhoun DA. 24-Hour ambulatory blood pressure control with triple-therapy amlodipine, valsartan and hydrochlorothiazide in patients with moderate to severe hypertension. J Hum Hypertens. 2011 Oct;25(10):615-22. doi: 10.1038/jhh.2010.115. Epub 2011 Jan 20.