Efficacy and Safety of Valsartan Plus Hydrochlorothiazide in Fixed Dose Combination in Hypertensive Patients Not Controlled by the Free Combination of an Angiotensin Receptor Blocker Plus Hydrochlorothiazide

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Amlodipine; Drug: Candesartan plus Hydrochlorothiazide; Drug: Valsartan plus Hydrochlorothiazide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00360178

CVAH631BDE13

Details and patient eligibility

About

Recruiting in Germany only:

This study will evaluate the safety and efficacy of valsartan plus HCTZ in fixed dose combination in hypertensive patients not responding to treatment with the free combination of Candesartan plus HCTZ. In an optional extension patients with uncontrolled BP at the end of the core study can be treated with valsartan plus HCTZ in fixed dose combination plus amlodipine 5 mg for additional 4 weeks.

Enrollment: 198 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female patients (>=18 years)
2. Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods (e.g. intra-uterine device, hormonal contraceptives).
3. Patients with moderate essential hypertension (WHO):

Exclusion criteria

1. Severe hypertension (WHO)
2. Pregnant or nursing women
3. Treated hypertensive patients with controlled hypertension under current therapy (MSDBP < 90 mmHg and MSSBP < 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)