The Effects of Moderate vs. Aggressive Treatment With Valsartan + Amlodipine on Patients With Hypertension Uncontrolled by Angiotensin-Receptor Blocker (Herein, ARB) Monotherapy

A Multicenter, Randomized, Double Blind, Parallel Design Trial to Evaluate the Blood Pressure Lowering Efficacy Comparing Moderate Versus Aggressive Treatment Regimen of Valsartan + Amlodipine in Patients Uncontrolled on ARB Monotherapy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00666536

Acronym

EXTRA

Enrollment

728

Registered

2008-04-25

Start date

2008-03-31

Completion date

Unknown

Last updated

2016-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Hypertension, adults, Valsartan + Amlodipine, Angiotensin Receptor Blockers

Brief summary

The purpose of this trial is to compare blood pressure lowering efficacy of moderate Valsartan + Amlodipine treatment regimen (160 / 5 mg) with that of aggressive regimen (320 / 10 mg) in patients uncontrolled on ARB monotherapy, other than Valsartan

Interventions

DRUGvalsartan and amlodipine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male and female outpatients * 18 Years of age or older * Mean Sitting Systolic Blood Pressure (the top number) greater than or equal to 150 mmHg and lower than 200 mmHg while on Angiotensin-Receptor Blocker monotherapy for a minimum period of 28 days prior to randomization

Exclusion criteria

* Mean Sitting Systolic Blood Pressure (the top number) greater than or equal to 200 mmHg and/or Mean Sitting Diastolic Blood Pressure greater than or equal to 120 mmHg * Transient ischemic attack (mini-stroke), myocardial infarction (heart attack), all types of revascularization procedures in the last 6 months * Treatment with valsartan or any combination antihypertensive treatment with 28 days prior to screening (Visit 1)

Design outcomes

Primary

Measure	Time frame
Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP)	Baseline and Week 4

Secondary

Measure	Time frame
Percentage of Patients Achieving the Blood Pressure (BP) Goal of < 140/90 mmHg at Weeks 2,4,8 and 12	Weeks 2, 4, 8 and 12
Change From Baseline to Week 4 in Mean Sitting Diastolic Blood Pressure (MSDBP)	Baseline and Week 4
Change From Baseline to Weeks 2, 8 and 12 in MSSBP	Baseline and Weeks 2, 8 and 12
Change From Baseline to Weeks 2, 8 and 12 in MSDBP	Baseline and Weeks 2, 8 and 12
Percentage of Patients Achieving BP Goal of MSSBP < 140mmHg at Weeks 2, 4, 8 and 12	Weeks 2, 4, 8 and 12

Countries

United States

Participant flow

Pre-assignment details

369 and 359 are the total randomized patients by treatment groups respectively. In the baseline measures tables 366 and 357 are the total patients for the ITT population by treatment group.

Participants by arm

Arm	Count
Aggressive Treatment Regimen (5/320 mg to 10/320 mg) Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)	366
Moderate Treatment Regimen (5/160 mg) Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)	357
Total	723

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	9	19
Overall Study	Lost to Follow-up	4	3
Overall Study	Protocol deviation(s)	8	6
Overall Study	Unsatisfactory therapeutic effect	2	0
Overall Study	Withdrawal by Subject	10	9

Baseline characteristics

Characteristic	Total	Moderate Treatment Regimen (5/160 mg)	Aggressive Treatment Regimen (5/320 mg to 10/320 mg)
Age, Continuous	54.7 years STANDARD_DEVIATION 10.98	55.0 years STANDARD_DEVIATION 10.98	54.4 years STANDARD_DEVIATION 10.98
Age, Customized < 65 years	594 participants	292 participants	302 participants
Age, Customized >=65 years	129 participants	65 participants	64 participants
Sex: Female, Male Female	314 Participants	157 Participants	157 Participants
Sex: Female, Male Male	409 Participants	200 Participants	209 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	50 / 369	29 / 359
serious Total, serious adverse events	4 / 369	10 / 359