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Completed

NCT Number: NCT00344110

Study Comparing SPP100 (Aliskiren) 150mg to Placebo and to Losartan 50mg in Patients With Mild to Moderate Essential Hypertension

Assessing efficacy, safety and pharmacokinetics in patients with mild to moderate essential hypertension

Completed

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Pharmaceuticals

Japan

Who can participate

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

Inclusion criteria

  • Age: 20 - 75 years old
  • Gender: Male or female
  • Status: Outpatients
  • Mild to moderate essential hypertension

Exclusion criteria

  • Pregnant women, lactating mothers, women suspected of being pregnant, or women who wish to be pregnant
  • Patients with msSBP >==180 mmHg and/or msDBP >=110 mmHg at Visit 1, 2 or 3
  • Patients with or suspected of having secondary hypertension (due to aortic coarctation, primary aldosteronism, etc.)
  • Patients suspected of having malignant hypertension

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Aliskiren

Drug

Primary outcomes

  1. Mean sitting diastolic blood pressure (msDBP) lowering from baseline to the study end to placebo and losartan

Secondary outcomes

  1. Mean sitting systolic pressure (msSBP) lowering from baseline to the study end to placebo and losartan

  2. Successful response; msDBP <90mmHg and/or a reduction of msDBP ≥ 10mmHg

  3. Control rate; msDBP <90mmHg and msSBP<140mmHg

  4. The pharmacokinetics / pharmacodynamics

  5. Safety and tolerability

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo and Active-controlled, Multicenter, Parallel-group Study Comparing SPP100 (Aliskiren) 150mg to Placebo and to Losartan 50mg to Evaluate Efficacy, Safety and Pharmacokinetics in Patients With Mild to Moderate Essential Hypertension

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jun 26, 2006
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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