Phase 3 N=257 Treatment

Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension

Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT00523744 ↗

Enrolled (actual)

257

Serious AEs

0.2%

Results posted

May 2011

Primary outcome: Primary: Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study — -9.13 mmHg

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Amlodipine (Drug); Olmesartan medoxomil (Drug); Amlodipine+valsartan (Drug); Hydrochlorothiazide (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis
Primary completion: Dec 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study	-9.13	—
PRIMARY Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study	-5.22	—
SECONDARY Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study	-7.87	—
SECONDARY Change in Sitting Pulse Pressure During the Core Phase of the Study	1.26	—
SECONDARY Change in Sitting Pulse Rate During the Core Phase of the Study	-1.93	—
SECONDARY Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study	44.6; 72.6	—
SECONDARY Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study	47.4; 73.1	—
SECONDARY Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study	-10.84	—
SECONDARY Change in Sitting Pulse Pressure During the Extension Phase of the Study	-5.62	—
SECONDARY Change in Sitting Pulse Rate During the Extension Phase of the Study	0.09	—
SECONDARY Percentage of Patients Who Achieved Normalized Blood Pressure During the Extension Phase of the Study	59.3; 83.5	—
SECONDARY Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Extension Phase of the Study	61.5; 83.5	—

Summary

This study will evaluate the efficacy and safety of valsartan and amlodipine in fixed dose combination in adults with moderate, inadequately controlled hypertension. There was an optional study extension for eligible patients who wanted to participate that contains the triple therapy (ie, hydrochlorothiazide+ amlodipine/valsartan).

Eligibility Criteria

Inclusion Criteria for Core study:

Male or female patients (>=18 years)
Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods
Patients with essential hypertension (diastolic blood pressure >=100 mmHg and = 140 mmHg and/or msDBP >= 90 mmHg at week 8 ie, end of core study.

Exclusion Criteria for Core study:

Severe hypertension (diastolic blood pressure >=110 mmHg or systolic blood pressure >= 180 mmHg)
Pregnant or nursing women
Treated hypertensive patients with controlled hypertension under current therapy
A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV

Exclusion Criteria for Extension:

prematurely discontinued the core study
failed to comply with the core study protocol

Other protocol-defined inclusion/exclusion criteria applied to the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00523744). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.