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OpenTrials
Completed

NCT Number: NCT00262236

Efficacy and Safety of Aliskiren and Atenolol in Adults (>18) With Mild to Moderate Hypertension

This is a study for people diagnosed with hypertension to compare the safety and effectiveness of aliskiren alone and in combination with atenolol. Each patient will be in the study for 12 weeks.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigative Centers, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Outpatients 18 years of age and older.
  • Patients with essential hypertension.

Exclusion criteria

Severe hypertension, Current diagnosis of heart failure, History or evidence of a secondary form of hypertension, Participation in any investigational drug study within one month of planned participation,

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Aliskiren

Drug

Primary outcomes

  1. Change from baseline in diastolic blood pressure after 12 weeks

Secondary outcomes

  1. Change from baseline in systolic blood pressure after 12 weeks

  2. Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 12 weeks

  3. Blood pressure of < 140/90 mmHg after 12 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Twelve-week, Randomized, Double-blind, Parallel-group, Multicenter, Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Atenolol in Patients With Essential Hypertension

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Dec 6, 2005
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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