Safety and Efficacy of Valsartan Plus Hydrochlorothiazide and Amlodipine in Hypertensive Patients

NCT00426478 | Completed Phase 4

• 1 other identifier: CVAH631BTW02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

AMPM, SBP, DBP, Valsartan plus Hydrochlorothiazide, Amlodipine, high blood pressure

Outcome Measures

Primary Outcomes (1)

• Change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks treatment

Secondary Outcomes (2)

• Change from baseline in mean sitting diastolic blood pressure (msDBP) after 8 weeks treatment

• Change from baseline in Ambulatory Blood Pressure Measurement (ABPM) parameters after 8 weeks treatment

Interventions

Valsartan plus Hydrochlorothiazide (80mg/12.5mg) DRUG

Amlodipine (5mg) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

National Taiwan University

Taipei, R.o.c, 100, Taiwan

Location

MeSH Terms

Conditions

Hypertension

Interventions

Valsartan; Hydrochlorothiazide; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dihydropyridines; Pyridines

Study Officials

• Jeremiah CHAO, MD

  National Taiwan Univ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 23, 2007
• First Posted: January 24, 2007
• Study Start: November 1, 2006
• Study Completion: September 1, 2007
• Last Updated: August 22, 2008

Record last verified: 2008-08

Locations

TW (1)