FindTrial
Sign In

A Year Long Study to Evaluate the Safety of the Combination of Valsartan (320 mg) and Amlodipine (5 mg) in Patients With Hypertension

A 54 Week, Extension to the Double-blind, Multicenter, Multifactorial, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Valsartan (160 mg and 320 mg) and Amlodipine (10 mg) Combined and Alone in Hypertensive Patients

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00170976
Enrollment
403
Registered
2005-09-15
Start date
2004-04-30
Completion date
2005-06-30
Last updated
2023-10-12

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

Conditions

HYPERTENSION

Keywords

HYPERTENSION, VALSARTAN, AMLODIPINE< SAFETY

Brief summary

A ONE YEAR SAFETY STUDY FOR PATIENTS WHO COMPLETE STUDY VAA489A2307.

Interventions

DRUGvalsartan + amlodipine

Sponsors

Novartis
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* SUCCESSFUL COMPLETION OF VAA489A2307 CORE TRIAL * VISIT 7 BLOOD PRESSURE MUST BE MSDBP ≤ 95 mmHg AND MSSBP ≤ 150 mmHg

Exclusion criteria

* PATIENTS WHO EXPERIENCED ANY ADVERSE EVENTS CONSIDERED SERIOUS AND DRUG RELATED IN VAA489A2307 CORE Other protocol-defined

Design outcomes

Primary

MeasureTime frame
Adverse events and serious adverse events at each study visit for 6 or 12 months—

Secondary

MeasureTime frame
Change from baseline in diastolic blood pressure from baseline after 6 or 12 months—
Change from baseline in systolic blood pressure from baseline after 6 or 12 months—
Change from baseline in standing diastolic and systolic blood pressure after 6 or 12 months—
Change from baseline in sitting and standing pulse after 6 or 12 months—
Hematology and blood chemistry after 6 or 12 months—

Countries

Germany, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026