Clinical trial NCT00698646: Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Compared to Valsartan Monotherapy or Hydrochlorothiazide Monotherapy in Elderly (>70) With Mild-moderate Hypertension.
Official title: A 16 Week Multi-center, Randomized, Double-blind Study to Evaluate Efficacy and Safety of Valsartan/Hydrochlorothiazide (HCTZ) Combination Therapy Compared to Patients Initiated With Valsartan Monotherapy or Hydrochlorothiazide (HCTZ) Monotherapy in Very Elderly Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Systolic blood pressure
Diastolic blood pressure
Valsartan
Hydrochlorothiazide
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-06-17
Enrollment: 384
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety and efficacy of initial treatment therapy with valsartan/hydrochlorothiazide (HCTZ) versus the initial treatment therapy with monotherapies (valsartan or HCTZ) in the very elderly patients (greater than or equal to 70 years) with stage 1 or 2 hypertension


Eligibility criteria: Inclusion Criteria:

* Age 70 years or older.
* Patients with hypertension prior to being randomized into study.
* Patients must have an office cuff MSSBP ≥ 140 and ≤ 200 mmHg systolic.
* Have the ability to communicate and comply with all study requirements.
* Provide written informed consent to participate in the study prior to any screening or study procedures.

Exclusion Criteria:

* Use of other investigational drugs within 30 days of enrollment.
* History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
* Office blood pressure measured by office machine cuff with a mean of (3) MSDBP ≥ 120 mmHg at anytime during the screening / washout period.
* Patients taking 3 or more antihypertensive drugs and MSSBP ≥ 160 mmHg at the time of Visit 1.
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)
timeFrame: Baseline and Week 4
Secondary outcomes:
measure: Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)
timeFrame: Baseline and Weeks 4, 8, 12 and 16
measure: Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)
timeFrame: Baseline and Weeks 8, 12, and 16
measure: Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg
timeFrame: Weeks 4, 8, 12 and 16
measure: Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)
timeFrame: Weeks 4, 8, 12 and 16
measure: Time in Weeks to Achieving the First Treatment Success (Defined as the Time of the First Achievement of the Target Blood Pressure Goal [MSSBP/MSDBP <140/90 mmHg])
timeFrame: During 16 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigative site
state: Alabama
city: Phoenix
country: United States
facility: Investigative site
state: Arizona
city: Escondido
country: United States
facility: Investigative Site
state: California
city: Fresno
country: United States
facility: Investigative site
state: California
city: Huntington Park
country: United States
facility: Investigative site
state: California
city: Pismo Beach
country: United States
facility: Investigative Sites
state: California
city: Miami
country: United States
facility: Investigative site
state: Florida
city: Ormond Beach
country: United States
facility: Investigative site
state: Florida
city: Conyers
country: United States
facility: Investigative site
state: Georgia
city: Lexington
country: United States
facility: Investigative Site
state: Kentucky
city: Portland
country: United States
facility: Investigative site
state: Maine
city: Las Vegas
country: United States
facility: Investigative site
state: Nevada
city: Buffalo
country: United States
facility: Investigative site
state: New York
city: Shelby
country: United States
facility: Investigative site
state: North Carolina
city: Carlisle
country: United States
facility: Investigative site
state: Ohio
city: Oklahoma City
country: United States
facility: Investigative site
state: Oklahoma
city: Erie
country: United States
facility: Investigative site
state: Pennsylvania
city: Greer
country: United States
facility: Investigative Site
state: South Carolina
city: Taylors
country: United States
facility: Investigative Site
state: South Carolina
city: St George
country: United States
facility: Investigative site
state: Utah
Study officials:
References:
citation: Cushman WC, Duprez DA, Weintraub HS, Purkayastha D, Zappe D, Samuel R, Izzo JL Jr. Home and clinic blood pressure responses in elderly individuals with systolic hypertension. J Am Soc Hypertens. 2012 May-Jun;6(3):210-8. doi: 10.1016/j.jash.2012.03.001.
citation: Weintraub HS, Duprez DA, Cushman WC, Zappe DH, Purkayastha D, Samuel R, Izzo JL Jr. Antihypertensive response to thiazide diuretic or angiotensin receptor blocker in elderly hypertensives is not influenced by pretreatment plasma renin activity. Cardiovasc Drugs Ther. 2012 Apr;26(2):145-55. doi: 10.1007/s10557-011-6365-x.
citation: Izzo JL Jr, Weintraub HS, Duprez DA, Purkayastha D, Zappe D, Samuel R, Cushman WC. Treating systolic hypertension in the very elderly with valsartan-hydrochlorothiazide vs. either monotherapy: ValVET primary results. J Clin Hypertens (Greenwich). 2011 Oct;13(10):722-30. doi: 10.1111/j.1751-7176.2011.00498.x. Epub 2011 Jul 14.
citation: Duprez DA, Weintraub HS, Cushman WC, Purkayastha D, Zappe D, Samuel R, Izzo JL Jr. Effect of valsartan, hydrochlorothiazide, and their combination on 24-h ambulatory blood pressure response in elderly patients with systolic hypertension: a ValVET substudy. Blood Press Monit. 2011 Aug;16(4):186-96. doi: 10.1097/MBP.0b013e32834944e9.