Efficacy and Safety of the Combination of Valsartan Plus Amlodipine in Hypertensive Patients Not Adequately Responding to the Combination Therapy With Ramipril Plus Felodipine

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00367939
• Collaborator: (none)
• Enrollment: 132
• Location: 1
• Duration (Months): 7
• Patients Per Site Per Month: 19

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy of valsartan plus amlodipine in hypertensive patients not responding to treatment with ACE inhibitor plus calcium channel blocker

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: valsartan + amlodipine	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 132 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Multicenter Study to Evaluate the Efficacy and Safety of a 5 Week Therapy With the Combination of Valsartan 160 mg Plus Amlodipine 10 mg in Hypertensive Patients Not Adequately Responding to a 5 Week Therapy With Ramipril 5 mg and Felodipine 5 mg
• Study Start Date: Dec 1, 2005
• Actual Primary Completion Date: Jul 1, 2006
• Actual Study Completion Date: Jul 1, 2006

Outcome Measures

Primary Outcome Measures

1. To investigate whether 5 weeks of treatment with valsartan 160mg + amlodipine 10mg provide add'l mean sitting systolic BP reduction in patients not adequately responding to 5 weeks of treatment with ramipril + felodipine--i.e., mean systolic BP []

Secondary Outcome Measures

1. To evaluate the effects of valsartan 160 mg plus amlodipine 10 mg on mean sitting diastolic BP, normalization and responder rate. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• Male or female patients (18 years or older)

• Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods (e.g. barrier method with spermicide, intra-uterine device, hormonal contraceptives).

• Patients with moderate essential hypertension (WHO II)

Exclusion Criteria:

• Severe hypertension

• Pregnant or nursing women

• Treated hypertensive patients with controlled hypertension under current therapy (MSDBP < 90 mmHg and MSSBP < 140 mmHg)

• 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 exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Investigative Centers		Germany

Sponsors and Collaborators

• Novartis

Investigators

• Study Director: Novartis Pharma Ag, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT00367939
• Other Study ID Numbers: CVAA489ADE01
• First Posted: Aug 24, 2006
• Last Update Posted: May 18, 2017
• Last Verified: May 1, 2017

• Keywords provided by Novartis: Hypertension
• Additional relevant MeSH terms: Hypertension; Amlodipine; Valsartan

Study Results

No Results Posted as of May 18, 2017