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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: valsartan + amlodipine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis +41 61 324 1111, Study Director, Affiliation: Novartis

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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 outcome:

Mean sitting diastolic blood pressure (analogously & explorative)

Normalization (analogously & explorative)

Responder rate. (analogously & explorative)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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/exclusion criteria may apply.

Locations and Contacts

Investigative Centers, Germany

Novartis, Basel, Switzerland

Additional Information

Starting date: August 2006
Last updated: November 7, 2011

Page last updated: August 23, 2015

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