A Study to Evaluate the Combination of Valsartan + Amlodipine in Hypertensive Patients

An Multicenter Study to Evaluate the Efficacy and Tolerability of a 4-week Therapy With the Combination of Valsartan 160mg + Amlodipine 5mg in Hypertensive Patients Not Adequately Responding to 4-week Treatment With Amlo 5mg or Felodipine 5mg in Monotherapy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00392262

Enrollment

224

Registered

2006-10-25

Start date

2006-08-31

Completion date

2007-02-28

Last updated

2016-11-18

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

Conditions

Hypertension

Keywords

Moderate essential hypertension (WHO grade II)

Brief summary

The purpose of this study is to evaluate the efficacy of valsartan plus amlodipine in hypertensive patients not responding to treatment with amlodipine or felodipine alone.

Interventions

DRUGvalsartan + amlodipine

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

1. Male or female patients (18 years) 2. Patients with moderate essential hypertension (untreated must have MSSBP ≥160 and \<180 mmHg at Visit 1, treated must have MSSBP \<180 mmHg at Visit 1) (WHO grade II)

Exclusion criteria

1. Severe hypertension(MSDBP ≥110 mmHg or MSSBP ≥ 180 mmHg) 2. Pregnant or nursing women 3. Treated hypertensive patients with controlled hypertension under current therapy (diastolic BP \< 90 mmHg and systolic BP \< 140 mmHg) 4. 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 Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
To investigate whether 4 weeks treatment with valsartan 160mg + amlo 5mg provide an add'l mean sitting systolic blood pressure reduction in patients not adequately responding to 4 weeks treatment with amlo 5mg or felodipine 5mg	—

Secondary

Measure	Time frame
Mean sitting diastolic blood pressure (analogously & explorative)	—
Normalization (analogously & explorative)	—
Responder rate. (analogously & explorative)	—

Countries

Germany, Switzerland

Outcome results

None listed

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