Efficacy & Safety of Orally Administered Valsartan/Amlodipine Combo Therapy vs Amlodipine Monotherapy in Patients With Stage II Hypertension
This study has been completed.
Sponsor:
Novartis
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00350168
First received: July 7, 2006
Last updated: November 7, 2011
Last verified: November 2011
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Purpose
The purpose of this study is to evaluate the blood pressure lowering effects of a valsartan/amlodipine combination treatment and amlodipine monotherapy for the treatment of stage II hypertensive patients (MSSBP ≥ 160 mmHg).
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: valsartan + amlodipine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | An 8-week Multicenter Study to Evaluate the Efficacy and Safety of Orally Administered Valsartan/Amlodipine Combination Based Therapy Versus Amlodipine Monotherapy in Patients With Stage II Hypertension |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Change from baseline in MSSBP at week 4
Secondary Outcome Measures:
- Change from baseline MSSBP after 2 and 8 weeks of treatment
- Change from baseline MSDBP after 2, 4 and 8 weeks of treatment
- Proportion of patients reaching overall BP control (MSSBP < 140 mmHg and MSDBP < 90mmHg) after 8 weeks of treatment
- Evaluation of safety and tolerability after 8 weeks of treatment
| Enrollment: | 647 |
| Study Start Date: | June 2006 |
| Study Completion Date: | April 2007 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
Criteria
Inclusion Criteria:
- 18 years of age or older.
- Moderate to severe high blood pressure. This is defined as a systolic pressure (the top number) greater than or equal to 160 mmHg and less than 200 mmHg.
Exclusion Criteria:
- History of allergy or hypersensitivity to ARBs, CCBs, thiazide diuretics
- Inability to stop all prior blood pressure medications safely
- Systolic BP ≥ 200 mmHg and/or diastolic BP ≥ 120 mmHg
- Controlled blood pressure (systolic BP < 140 mmHg) taking more than 3 antihypertensive medications at screening
- Systolic BP ≥ 140 mmHg and < 180 mmHg taking more than two antihypertensive medications at screening
- Systolic BP ≥ 180 mmHg taking more than one antihypertensive medication at screening
- History of stroke, angioplasty, coronary artery bypass graft surgery, heart attack or unstable angina
- Type 1 diabetes
- Poorly controlled Type 2 diabetes
- History of heart failure
- Arrhythmia
- Significant valvular heart disease
- Active gout
- History of autoimmune diseases
- History of multiple drug allergies
- Liver disease
- Pancreatic injury within 1 year of screening
- Evidence of kidney impairment or history of dialysis
- Any surgical or medical condition which might alter the absorption, distribution, metabolism, or excretion of any drug. This could include currently active gastritis, ulcers, or gastrointestinal/rectal bleeding, or urinary tract obstruction.
- Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, would be excluded UNLESS they are post-menopausal, surgically sterile OR are using acceptable methods of contraception. The use of hormonal contraceptives is not allowed
- Pregnant or nursing (lactating) women
- History of malignancy of any organ system within the past five years
- Any severe, life-threatening disease within the past five years
- History of drug or alcohol abuse within the last 2 years.
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00350168
Locations
| United States, New Jersey | |
| Novartis Pharmaceuticals Corp | |
| E. Hanover, New Jersey, United States, 07936 | |
Sponsors and Collaborators
Novartis
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00350168 History of Changes |
| Other Study ID Numbers: | CVAA489A2403 |
| Study First Received: | July 7, 2006 |
| Last Updated: | November 7, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novartis:
|
Blood pressure Venous pressure Systolic pressure Diastolic pressure Pulse pressure |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Amlodipine Valsartan Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Vasodilator Agents Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |
ClinicalTrials.gov processed this record on May 21, 2013