Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension

Condition(s) targeted: Hypertension

Intervention: Amlodipine (Drug); Olmesartan medoxomil (Drug); Amlodipine+valsartan (Drug); Hydrochlorothiazide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Sponsor GmbH

This study will evaluate the efficacy and safety of valsartan and amlodipine in fixed dose combination in adults with moderate, inadequately controlled hypertension. There was an optional study extension for eligible patients who wanted to participate that contains the triple therapy (ie, hydrochlorothiazide+ amlodipine/valsartan).

Official title: An Open-label, Multicenter Study to Evaluate the Efficacy and Tolerability of a 4 Week Therapy With the Fixed Dose Combination of Amlodipine 10 mg Plus Valsartan 160 mg in Hypertensive Patients Not Adequately Responding to a 4 Week Therapy With the Free Combination of an Angiotensin Receptor Blocker (Olmesartan 20 mg) Plus Amlodipine 10 mg

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

Primary outcome:

Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study

Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study

Secondary outcome:

Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study

Change in Sitting Pulse Pressure During the Core Phase of the Study

Change in Sitting Pulse Rate During the Core Phase of the Study

Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study

Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study

Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study

Change in Sitting Pulse Pressure During the Extension Phase of the Study

Change in Sitting Pulse Rate During the Extension Phase of the Study

Percentage of Patients Who Achieved Normalized Blood Pressure During the Extension Phase of the Study

Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Extension Phase of the Study

Detailed description: Title of study extension: An open-label, multicenter extension to evaluate the efficacy and tolerability of a 4 week therapy with hydrochlorothiazide 12. 5 mg plus amlodipine 10 mg/valsartan 160 mg in hypertensive patients not adequately responding to a 4 week therapy each with the combinations of olmesartan 20 mg plus amlodipine 10 mg followed by amlodipine 10 mg/valsartan 160 mg

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

Criteria:

Inclusion Criteria for Core study:

- Male or female patients (>=18 years)

- Females must be either post-menopausal for one year, surgically sterile or using

effective contraceptive methods

- Patients with essential hypertension (diastolic blood pressure >=100 mmHg and <110

mmHg) Inclusion Criteria for Extension:

- Patients had to have a msSBP >= 140 mmHg and/or msDBP >= 90 mmHg at week 8 ie, end of

core study. Exclusion Criteria for Core study:

- Severe hypertension (diastolic blood pressure >=110 mmHg or systolic blood pressure

>= 180 mmHg)

- Pregnant or nursing women

- Treated hypertensive patients with controlled hypertension under current therapy

- 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

Exclusion Criteria for Extension:

- prematurely discontinued the core study

- failed to comply with the core study protocol

Other protocol-defined inclusion/exclusion criteria applied to the study.

Novartis Investigative Site, , Germany, Schwerin, Germany

30 sites in Germany, TBD, Germany

Starting date: July 2007
Last updated: June 8, 2011