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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00902304




Registration number
NCT00902304
Ethics application status
Date submitted
28/04/2009
Date registered
15/05/2009
Date last updated
4/12/2012

Titles & IDs
Public title
Valsartan Intensified Primary Care Reduction of Blood Pressure Study
Scientific title
A Phase IV Clinical Trial of Intensified Blood Pressure Management in Primary Care Using Valsartan Alone and as Combination Anti-Hypertensive Therapy
Secondary ID [1] 0 0
CVAL489AAU01
Universal Trial Number (UTN)
Trial acronym
VIPER-BP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Valsartan and hydrochlorothiazide (HCTZ) - monotherapy
Treatment: Drugs - Valsartan and amlodipine
Treatment: Drugs - Usual care
Treatment: Drugs - Valsartan
Treatment: Drugs - Valsartan and hydrochlorothiazide (HCTZ) - combination arm

Active comparator: Usual care - Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target

Experimental: Monotherapy (initial monotherapy arm) - Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.

Experimental: Combination (initial combination therapy arm) - Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.


Treatment: Drugs: Valsartan and hydrochlorothiazide (HCTZ) - monotherapy
Monotherapy arm - if monotherapy valsartan 320mg per day orally was not sufficient, then could add HCTZ up to 25 mg per day orally

Treatment: Drugs: Valsartan and amlodipine
From valsartan 80mg/amlodipine 5mg per day to valsartan 160mg/amlodipine 10mg per day orally

Treatment: Drugs: Usual care
As directed by investigator

Treatment: Drugs: Valsartan
Valsartan 160mg per day to 320mg per day orally

Treatment: Drugs: Valsartan and hydrochlorothiazide (HCTZ) - combination arm
Combination arm - from valsartan 80mg/hydrochlorothiazide 12.5mg per day to valsartan 160mg/hydrochlorothiazide 25mg per day orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Patients Who Have Achieved Their Pre-specified (Individualized National Heart Foundation of Australia Criteria) Blood Pressure (BP) Target
Timepoint [1] 0 0
26 weeks
Secondary outcome [1] 0 0
Change in Mean Sitting Systolic Blood Pressure
Timepoint [1] 0 0
Baseline and 26 weeks
Secondary outcome [2] 0 0
Change in Mean Sitting Diastolic Blood Pressure
Timepoint [2] 0 0
Baseline and 26 weeks
Secondary outcome [3] 0 0
Change in Absolute Cardiovascular Risk Score
Timepoint [3] 0 0
Baseline and 26 weeks
Secondary outcome [4] 0 0
Number of Patients With at Least One Adverse Events Attributable to Anti-hypertensive Therapy
Timepoint [4] 0 0
26 weeks
Secondary outcome [5] 0 0
Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments
Timepoint [5] 0 0
26 weeks
Secondary outcome [6] 0 0
Change in the EQ-5D Score
Timepoint [6] 0 0
Baseline and 26 weeks
Secondary outcome [7] 0 0
Number of Patients With Depression
Timepoint [7] 0 0
Baseline and week 26
Secondary outcome [8] 0 0
Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline to Week 26
Timepoint [8] 0 0
Baseline and week 26
Secondary outcome [9] 0 0
Participants With End Organ Disease at Baseline and Week 26
Timepoint [9] 0 0
Baseline and week 26
Secondary outcome [10] 0 0
Change in Self-care Behavior Score From Baseline to Week 26
Timepoint [10] 0 0
Baseline and week 26
Secondary outcome [11] 0 0
Rate of Treatment Compliance
Timepoint [11] 0 0
26 weeks
Secondary outcome [12] 0 0
Number of Patients With Major Clinical Endpoints
Timepoint [12] 0 0
26 weeks

Eligibility
Key inclusion criteria
* newly diagnosed or currently treated hypertensive patients who have not attained their blood pressure target and require active pharmacological treatment as recommended by the local guidelines as judged by the general practitioner
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* significantly elevated blood pressure (severe hypertension)
* requiring 3 or more antihypertensive drugs
* severe kidney disease or dialyses
* clinical diagnosis requiring concomitant therapy with antihypertensive treatment that would be outside the therapies allowed under study protocol

Other protocol-defined inclusion/exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2011
Sample size
Target
Accrual to date
Final
2337
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Professor Garry Jennings-Co Principal Investigator - Melbourne
Recruitment hospital [2] 0 0
Professor Simon Stewart-Principal Investigator - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Baker Heart and Diabetes Institute
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study will assess the efficacy of an intensive blood pressure management strategy compared to usual care in a primary care (general practice) setting.
Trial website
https://clinicaltrials.gov/study/NCT00902304
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00902304