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Low-dose Nifedipine-Valsartan Combination Compared to Up-titrated Valsartan Monotherapy in Essential Hypertension

NCT00993109 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2014-06-05

No results posted yet for this study

Summary

This will be a multi-center, prospective, randomized, open-label, parallel design, two arm comparator trial. In the proposed study, the investigators will compare low-dose combination therapy of Nifedipine GITS/OROS plus Valsartan with up-titrated monotherapy of Valsartan with respect to their blood pressure-decreasing effects in patients with essential hypertension.The study consists of a screening visit, followed by randomization and administration of either Nifedipine GITS/OROS 30 mg in combination with Valsartan 80 mg or Valsartan 160 mg for 12 weeks of treatment.The primary efficacy parameters will be mean SBP and DBP on office BP monitoring at 12 weeks of treatment compared to baseline.

Conditions

Interventions

DRUG

Adalat (Nifedipine, BAYA1040)

Nifedipine GITS/OROS 30 mg OM + Valsartan 80 mg OM

DRUG

Diovan (Valsartan)

Valsartan 160 mg OM (Two Valsartan 80mg tablets)

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • China
  • South Korea

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00993109 on ClinicalTrials.gov