Clinical trial NCT00426478: Safety and Efficacy of Valsartan Plus Hydrochlorothiazide and Amlodipine in Hypertensive Patients
Official title: The Comparison of the Antihypertensive Efficacy and Tolerability Between Valsartan Plus Hydrochlorothiazide 80mg/12.5mg and Amlodipine 5mg in the Essential Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: AMPM, SBP, DBP, Valsartan plus Hydrochlorothiazide, Amlodipine, high blood pressure
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-01-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A double-blind, active-controlled, randomized trial to compare Valsartan plus Hydrochlorothiazide 80mg/12.5mg and Amlodipine 5 mg.

Study design: 2 weeks washout, 8 weeks treatment period.


Eligibility criteria: Inclusion Criteria:

* Female or male patient with age ≧ 18 years old.
* Patient with mild to moderate uncomplicated essential hypertension, and the blood pressure not adequately controlled on existing antihypertensive treatment.
* Patient with sitting systolic blood pressure (sSBP)/ sitting diastolic blood pressure (sDBP) ≦ 180/110 mmHg at screening visit.
* For non-diabetic patient, sitting systolic blood pressure (sSBP) ≧ 140 mmHg or sitting diastolic blood pressure (sDBP) ≧ 90 mmHg at baseline visit; for diabetic patient, sitting systolic blood pressure (sSBP) ≧ 130 mmHg or sitting diastolic blood pressure (sDBP) ≧ 80 mmHg at baseline visit.
* Patient or his/her legally acceptable representative has signed and dated the informed consent form.

Exclusion Criteria:

* Known or suspected secondary hypertension.
* sSBP \> 180 mmHg or sDBP \> 110 mmHg at baseline visit.
* Patients taking more than two anti-hypertensive medications at the screening visit. (Fixed-dose combinations of two or more antihypertensive therapies will be counted as two or more antihypertensive medications.)
* Known NYHA functional class Chronic Heart Failure (CHF) III and IV.
* With a history of myocardial infarction, transient ischemic attack or cerebrovascular accident within the preceding 6 months, clinically significant valvular heart disease, or hepatic and/or renal dysfunction as defined by the following laboratory parameters
* SGPT (ALT) or SGOT (AST) \> two times upper the limit of normal range
* Serum creatinine \> 2.3 mg/dl or creatinine clearance \< 30 ml/min

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks treatment
Secondary outcomes:
measure: Change from baseline in mean sitting diastolic blood pressure (msDBP) after 8 weeks treatment
measure: Change from baseline in Ambulatory Blood Pressure Measurement (ABPM) parameters after 8 weeks treatment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University
state: R.o.c
Study officials:
affiliation: National Taiwan Univ
name: Jeremiah CHAO, MD
role: PRINCIPAL_INVESTIGATOR
References: