Efficacy and Safety of Valsartan and Amlodipine in Patients With Essential Hypertension

NCT00425373 | Completed Phase 2 Results

• 1 other identifier: CVAA489A1301
• Study Type: interventional
• Target: 1,474
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of fixed combination of valsartan (40 mg and 80 mg) and amlodipine (2.5 mg and 5 mg), valsartan and amlodipine alone, and placebo in reducing blood pressure. The study will investigate the dose response relationship for the combinations, monotherapies, and placebo.

Conditions

Essential Hypertension

Keywords

Hypertension, Valsartan, Amlodipine, high blood pressure

Outcome Measures

Primary Outcomes (1)

• Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to End of Study (Week 8)

  At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.

  Baseline to end of study (Week 8)

Secondary Outcomes (4)

• Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Study (Week 8)

  Baseline to end of study (Week 8)

• Percentage of Patients Achieving MSDBP < 90 mmHg or a => 10 mm Hg Decrease Compared to Baseline at the End of the Study (Week 8)

  Baseline to end of study (Week 8)

• Percentage of Patients Achieving MSDBP < 90mmHg at the End of the Study (Week 8)

  Baseline to end of study (Week 8)

• Percentage of Patients Achieving MSDBP < 90 mm Hg and MSSBP < 140 mm Hg at the End of the Study (Week 8)

  Baseline to end of study (Week 8)

Study Arms (9)

Valsartan + amlodipine 40/2.5 mg

EXPERIMENTAL

Drug: Valsartan + amlodipine 40/2.5 mg

Valsartan + amlodipine 40/5 mg

EXPERIMENTAL

Drug: Valsartan + amlodipine 40/5 mg

Valsartan + amlodipine 80/2.5 mg

EXPERIMENTAL

Drug: Valsartan + amlodipine 80/2.5 mg

Valsartan + amlodipine 80/5 mg

EXPERIMENTAL

Drug: Valsartan + amlodipine 80/5 mg

Valsartan 40 mg

ACTIVE COMPARATOR

Drug: Valsartan 40 mg

Valsartan 80 mg

ACTIVE COMPARATOR

Drug: Valsartan 80 mg

Amlodipine 2.5 mg

ACTIVE COMPARATOR

Drug: Amlodipine 2.5 mg

Amlodipine 5 mg

ACTIVE COMPARATOR

Drug: Amlodipine 5 mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Valsartan + amlodipine 40/2.5 mg DRUG

Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily

Valsartan + amlodipine 40/2.5 mg

Valsartan + amlodipine 40/5 mg DRUG

Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily

Valsartan + amlodipine 40/5 mg

Valsartan + amlodipine 80/2.5 mg DRUG

Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily

Valsartan + amlodipine 80/2.5 mg

Valsartan + amlodipine 80/5 mg DRUG

Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily

Valsartan + amlodipine 80/5 mg

Valsartan 40 mg DRUG

Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily

Valsartan 40 mg

Valsartan 80 mg DRUG

Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily

Valsartan 80 mg

Amlodipine 2.5 mg DRUG

Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily

Amlodipine 2.5 mg

Amlodipine 5 mg DRUG

Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily

Amlodipine 5 mg

Placebo DRUG

4 tablet and 2 capsule placebos taken once daily

Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with essential hypertension measured by electronic hemodynamometer. - - Patients must satisfy the following criteria.
• MSDBP \<110 mmHg and MSSBP \<180 mmHg at Visit 1
• MSDBP ≥ 90 mmHg and \< 110 mmHg and MSSBP \< 180 mmHg at Visit 2
• MSDBP ≥ 95 mmHg and \< 110 mmHg and MSSBP \< 180 mmHg at Visit 3
• The absolute difference in MSDBP between Visit 2 and 3 is ≤ 10 mmHg
• Male or female outpatients.
• Aged =\> 20 and =\< 80 years (at the time of signing informed consent).
• Patients who have written informed consent to participate in this study.

You may not qualify if:

• Pregnant women, nursing (lactating) mothers, women suspected of being pregnant, or women who wish to be pregnant during the study, women of child-bearing potential.
• Patients with secondary hypertension or suspected of having secondary hypertension.
• Patients with a history of malignant hypertension.
• Patients with an inability to completely discontinue all prior antihypertensive medications safely for a period of 12 weeks as required by the protocol.
• Patients with or with a history of any of the following diseases or signs: Cardiac disease, renal disease, cerebrovascular disorder
• Patients with a clinically significant allergy (asthma on pharmacotherapy, multi-drug allergy, or drug-induced or food-induced anaphylactic reactions).
• Patients hypersensitive to AII receptor antagonists, calcium channel blockers or dihydropyridine derivatives.
• Known moderate or malignant retinopathy.
• Patients with or with a history of pancreatitis. Patients with pancreatic injury, or evidence of impaired pancreatic function/injury within 12 months of Visit 1.
• Patients with any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug.
• Patients with volume depletion based on the investigator's or subinvestigator's clinical judgment using vital signs, skin turgor, moistness of mucous membrane and laboratory values.
• Patients who are found to have low Na and K (Na \<130 mEq/L, K \<3.3mEq/L) or high in these parameters (Na ≥ 152 mEq/L, K ≥ 5.2 mEq/L) by laboratory tests at Visit 1.
• Patients with type I diabetes mellitus on treatment with insulin, or patients with type II diabetes with poor glucose control defined as a glycosylated hemoglobin (HbA1c) \> 8.0% at Visit 1.
• Patients with or with a history of malignant tumors including leukemia and lymphoma, treated or untreated, within the past 5 years of Visit 1 whether or not there is evidence of local recurrence or metastases (except for localized basal cell carcinoma of the skin).
• Patients with any severe, life-threatening disease within the past 5 years. Patients with a history of autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Pharmaceuticals

Tokyo, 11111, Japan

Location

MeSH Terms

Conditions

Essential Hypertension; Hypertension

Interventions

Valsartan; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Dihydropyridines; Pyridines

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862 778-8300

Study Officials

• Novartis Japan

  Sponsor GmbH

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 22, 2007
• First Posted: January 23, 2007
• Study Start: November 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: April 29, 2011
• Results First Posted: February 4, 2011

Record last verified: 2011-04

Locations

JP (1)