Safety and Efficacy of Aliskiren + Hydrochlorothiazide in Patients With Moderate Hypertension - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00867490

Purpose

This study will assess the safety and efficacy of aliskiren plus hydrochlorothiazide in patients who do not achieve controlled blood pressure levels after treatment with another specified antihypertensive medication.

Condition	Intervention	Phase
Hypertension	Drug: Aliskiren /hydrochlorothiazide	Phase III

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of a 4 Week Therapy With the Aliskiren 300 mg Plus Hydrochlorothiazide 25 mg in Hypertensive Patients Not Adequately Responding to a 4 Week Therapy With Candesartan 32 mg Plus Hydrochlorothiazide 25 mg

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Aliskiren

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Mean diastolic blood pressure reduction [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Mean systolic blood pressure reduction [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Responder rate for blood pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Normalization rate for blood pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Safety and tolerability (e.g. AEs, laboratory, physical examinations) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Changes in heart rate [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	123
Study Start Date:	March 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Pts treated with Candesartan/hydrochlorothiazide (32 mg/25 mg)for 4 weeks. Nonresponders are then treated with Aliskiren/HCTZ(300 mg/25 mg for 4 additional weeks.	Drug: Aliskiren /hydrochlorothiazide Pts treated with Candesartan/hydrochlorothiazide (32 mg/25 mg)4 weeks. Nonresponders are then treated with Aliskiren/HCTZ(300 mg/25 mg.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with mean sitting diastolic blood pressure ≥ 100 mmHg and < 110 mmHg

Exclusion Criteria:

Patients with mean diastolic blood pressure ≥ 110 mmHg or mean systolic blood pressure ≥ 180 mmHg
Patients with prior stroke, hypertensive encephalopathy or heart attack
Patients with type 1 diabetes mellitus
Patients with type 2 diabetes mellitus with poor glucose control
Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00867490

Locations

Germany
Investigative Site
Chemnitz, Germany

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CSPH100ADE01
Study First Received:	March 20, 2009
Last Updated:	October 23, 2009
ClinicalTrials.gov Identifier:	NCT00867490 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Hypertension
aliskiren
cardiovascular diseases

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents

Hydrochlorothiazide
Pharmacologic Actions
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010