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| Sponsor: | Novartis |
|---|---|
| Information provided by (Responsible Party): | Novartis |
| ClinicalTrials.gov Identifier: | NCT00667719 |
Purpose
This study will test the safety of the combination of aliskiren/amlodipine/hydrochlorothiazide in patients with essential hypertension
| Condition | Intervention | Phase |
|---|---|---|
|
Essential Hypertension |
Drug: aliskiren /amlodipine/hydrochlorothiazide |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A 28 to 54-week, Open-label, Multicenter Study to Assess the Long-term Safety and Tolerability of the Combination of Aliskiren / Amlodipine / Hydrochlorothiazide in Patients With Essential Hypertension |
| Enrollment: | 564 |
| Study Start Date: | June 2008 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
aliskiren 300/mg + amlodipine 10 mg + hydrochlorothiazide
|
Drug: aliskiren /amlodipine/hydrochlorothiazide
1x aliskiren/amlodipine/hydrochlorothiazide
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
msDBP & msSBP Requirements:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| Investigative Site | |
| Houston, Texas, United States | |
| Belgium | |
| Investigative Site | |
| Belgium, Belgium | |
| Egypt | |
| Investigative Site | |
| Egypt, Egypt | |
| Germany | |
| Investigative Site | |
| Germany, Germany | |
| Poland | |
| Investigative Site | |
| Poland, Poland | |
| Slovakia | |
| Investigative Site | |
| Slovakia, Slovakia | |
| Spain | |
| Investigative Site | |
| Spain, Spain | |
| Turkey | |
| Investigative Site | |
| Turkey, Turkey | |
| Study Chair: | Novartis | Novartis |
More Information
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00667719 History of Changes |
| Other Study ID Numbers: | CSAH100A2301 |
| Study First Received: | April 24, 2008 |
| Last Updated: | August 22, 2011 |
| Health Authority: | United States: Food and Drug Administration; Belgium: Pharmaceutical Inspectorate; Germany: Federal Institute for Drugs and Medical Devices; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Slovakia: State Institute for Drug Control; Spain: Spanish Agency of Medicines; Turkey: Ministry of Health |
|
essential hypertension high blood pressure |
|
Hypertension Vascular Diseases Cardiovascular Diseases Hydrochlorothiazide Amlodipine Diuretics Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions |
Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Calcium Channel Blockers Vasodilator Agents |