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

• ClinicalTrials.gov Identifier: NCT00392262
• Recruitment Status: Completed
• First Posted: October 25, 2006
• Last Update Posted: November 18, 2016
• Sponsor: Novartis
• Information provided by (Responsible Party): Novartis

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 amlodipine or felodipine alone.

Condition or disease	Intervention/treatment	Phase
Hypertension	Drug: valsartan + amlodipine	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 224 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: August 2006
• Actual Primary Completion Date: February 2007
• Actual Study Completion Date: February 2007

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. 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 Measures :

1. Mean sitting diastolic blood pressure (analogously & explorative)
2. Normalization (analogously & explorative)
3. Responder rate. (analogously & explorative)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

Germany

Investigative Centers, Germany

Switzerland

Novartis

Basel, Switzerland

Sponsors and Collaborators

Novartis

Investigators

• Study Director: Novartis +41 61 324 1111; Novartis

More Information

Additional Information:

Results for CVAA489ADE03 from the Novartis Clinical Trials website 

Publications of Results:

Brachmann J, Ansari A, Mahla G, Handrock R, Klebs S. Effective and safe reduction of blood pressure with the combination of amlodipine 5 mg and valsartan 160 mg in hypertensive patients not controlled by calcium channel blocker monotherapy. Adv Ther. 2008 May;25(5):399-411. doi: 10.1007/s12325-008-0054-6.

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT00392262 History of Changes
• Other Study ID Numbers: CVAA489ADE03
• First Posted: October 25, 2006
• Last Update Posted: November 18, 2016
• Last Verified: November 2016

Keywords provided by Novartis:

Moderate essential hypertension (WHO grade II)

Additional relevant MeSH terms:

Amlodipine; Valsartan; Hypertension; Vascular Diseases; Cardiovascular Diseases; Antihypertensive Agents; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Vasodilator Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists