Valsartan and Amlodipine Compared to Losartan and Amlodipine in Hypertensive Patients

University of Pavia

Status and phase: Unknown; Phase 4

Conditions: Essential Hypertension

Treatments: Drug: losartan/amlodpine; Drug: valsartan/amlodpine

Study type: Interventional

Funder types: Other

Identifiers

NCT00716950

UNIPV004DIM2008

Details and patient eligibility

About

Hypertensive patients with moderate hypertension have a risk to develop cardiovascular events of 15-20% over a period of 10 years. It is important to reach quickly the advised target, but often this result can be obtained with a combination therapy. Some evidences demonstrate sartans and calcium channels blockers can be very useful and safe, but it is also important to verify which association can give side effects or give some pharmacokinetic interactions that can negatively influence the clinical combination efficacy.

Enrollment: 187 estimated patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diastolic blood pressure in sitting position 100 to 109 mmHg and systolic blood pressure > 140 mmHg at the end of the selection period

Exclusion criteria

• type 2 diabetes mellitus
• heart failure
• AMI in the previous 6 months
• angina pectoris
• secondary hypertension
• malignant hypertension
• women child-bearing potential
• women who are pregnant and lactating
• suspected history of allergy to the sartans or calcium channels blockers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

187 participants in 2 patient groups

1

Experimental group

Description:

valsartan/amlodipine

Treatment:

Drug: valsartan/amlodpine

2

Active Comparator group

Description:

losartan/amlodpine

Treatment:

Drug: losartan/amlodpine