Effectiveness of a Valsartan Based Versus an Amlodipine Based Treatment Strategy in naïve Patients With Stage 1 or Stage 2 Hypertension or in Patients Uncontrolled on Current Monotherapy

Hypertension Clinical Trial

Official title:

A 14 Week Study to Evaluate Effectiveness of a Valsartan Versus an Amlodipine Treatment Strategy in Achieving Blood Pressure Control in Patients With Stage 1 or Stage 2 Hypertension or Uncontrolled on Present Monotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00304226
• Other study ID #: CVAH631B2406
• Status: Completed
• Phase: Phase 4
• First received: March 16, 2006
• Last updated: November 15, 2016
• Start date: February 2006
• Est. completion date: January 2007

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial Summary

The population for this current study will include stage 1 and stage 2 hypertensive patients who are newly diagnosed or didn't have treatment during the last 3 months and patients who are currently treated but uncontrolled on present monotherapy.

The purpose of this study is to evaluate the efficacy of a treatment with valsartan versus a treatment with amlodipine in reaching blood pressure control after 14 weeks of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1288
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion criteria Stage/grade 1 or stage/ grade 2 hypertension, MSSBP = 140 mm Hg, and/ or MSDBP = 90 mm Hg, at Visit 1 and 2 in untreated patients Or Patients who are currently treated on monotherapy and uncontrolled and have a blood pressure = 160/100 mm Hg at Visit 1 and Visit 2

Exclusion criteria Current treatment with a CCB MSSBP = 180 mm Hg or MSDBP = 110 mm Hg at any time between visit 1 and Visit 2 History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures Evidence of a secondary form of hypertension Cerebrovascular accident or myocardial infarction during the last 12 months, prior to Visit 1 Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• valsartan

• amlodipine

Locations

Country	Name	City	State
Switzerland	Novartis Pharmaceuticals	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Germany,  Switzerland, 

References & Publications (1)

Zappe D, Papst CC, Ferber P; PROMPT Investigators.. Randomized study to compare valsartan +/- HCTZ versus amlodipine +/- HCTZ strategies to maximize blood pressure control. Vasc Health Risk Manag. 2009;5:883-92. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure less than 140/90 mmHg after 14 weeks
Secondary	Blood pressure less than 140/90 mmHg after 4, 8, and 11 weeks
Secondary	Blood pressure less than 140/90 mmHg after 4, 8, 11, and 14 weeks
Secondary	Time when blood pressure reaches less than 140/90 mmHg
Secondary	Change in blood pressure at baseline, week 4, 8, 11, and 14
Secondary	Adverse events and serious adverse events at each study visit for 14 weeks

External Links

•   Results for CVAH631B2406 from the Novartis Clinical Trials website